Thread: Cancer sucks

Actor Adan Canto died of appendiceal cancer at age 42. Here's what to know about the disease.

Kaitlin Reilly

Wed, January 10, 2024 at 10:37 PM GMT·4 min read

On Jan. 8, Designated Survivor actor Adan Canto died at age 42. The cause of death was appendiceal cancer, a rare disease that occurs when a tumor forms in the appendix. According to the Cleveland Clinic, appendiceal cancer affects about 1 to 2 people out of every 1 million in the U.S. Here’s what to know about it.

What is appendiceal cancer?
Appendiceal cancer is a type of cancer that originates in the appendix, a small pouch located in the abdomen. The appendix is part of the digestive system, although its exact function is not entirely clear, with some people theorizing it may play a role in immune function.

Around 50% of appendix cancers are known as carcinoid tumors, per the Cleveland Clinic. These tumors affect neuroendocrine cells, specialized cells in the body that release hormones that act as messengers to regulate various functions between the nervous system and the endocrine system. Generally, carcinoid tumors tend to grow slowly.

Appendiceal adenocarcinoma is a type of cancer that originates in the tissue that lines the inside of the appendix. There are different subtypes of appendiceal adenocarcinoma, each with unique characteristics. For example, colonic-type adenocarcinoma, which develops near the base of the appendix, often causes the patient to develop symptoms similar to colorectal cancer.

How is appendiceal cancer diagnosed?
Though it’s unclear how Canto was diagnosed specifically, appendiceal cancer is typically difficult to identify based on symptoms alone because many people don’t present with symptoms in its early stages.

"Unfortunately, there is no screening test," says Dr. Christopher Chen, a specialist in oncology and hematology at Stanford University School of Medicine. "Many cases are diagnosed unexpectedly when patients are taken for an appendectomy due to symptoms of acute appendicitis, like abdominal pain, nausea or bloating."

Appendicitis itself can be a warning sign of appendiceal cancer.

This type of cancer may also be found if the cancer spreads from the appendix to the abdomen, leading to more noticeable symptoms. These symptoms can include abdominal pain, bloating and bowel obstructions, or general cancer-related symptoms like unexplained weight loss and fatigue.

"Unfortunately, many patients present with late symptoms and are found to have advanced or metastatic disease," Dr. Alex Kim, a surgical oncologist who specializes in gastrointestinal cancers at the Ohio State University Comprehensive Cancer Center, tells Yahoo Life. "In these settings, we recommend for biopsy, which usually confirms the diagnosis of appendiceal cancer."

Dr. Kiran Turaga, Yale Cancer Center researcher and division chief of surgical oncology in Yale’s department of surgery, tells Yahoo Life that "currently, there is no screening test for it and often these are missed on colonoscopy." However, Turaga says there is a lot of evolving research in the use of liquid biopsy to help with screening for cancer in general, including appendix cancer.

How rare is it to be diagnosed with appendiceal cancer at 42?
Appendiceal cancer is rare, but it is most common among people ages 50 to 55, according to the National Institute of Cancer. It’s worth noting that certain types of cancer are rising rapidly among people younger than 50, and appendix cancer is one of them.

Turaga says it's not unheard of for someone to be diagnosed at age 42. "This disease occurs in young adults, and in fact we are seeing a fair number of cases in younger patients," he says. "It is still common for people in their 50s, but certain subtypes — like goblet cell adenocarcinoma — occurs in younger folks."

What are the risk factors?
Scientists do not know exactly why appendiceal cancer forms. However, Turaga says that recent research shows about 10% of patients have genetic mutations that can be related to appendix cancer. Some patients also seem to have autoimmune diseases that might be related to developing appendix cancer. Although experts say that both men and women can be affected by the disease, Johns Hopkins says that appendiceal cancer is more common in women than men.

Unlike some other types of cancer, appendiceal cancer does not tend to run in families. However, there are certain potential risk factors, such as smoking, that are associated with multiple types of cancer. Certain health conditions, including pernicious anemia and atrophic gastritis, which affects the stomach’s ability to produce acid, may also increase your risk for appendix cancer.

Actor Adan Canto died of appendiceal cancer at age 42. Here's what to know about the disease.

My mother had this, but luckily was detected early during an operation to remove benign ovarian cysts. The doctor said he could tell it was cancer as soon as he saw it, so he removed it. The pathology report confirmed it.

He also said she was incredibly lucky and should buy a lottery ticket.

She lived about another 20 years and died from other causes.

It sure does, one of my best buddies passed over Christmas. Been a bit of a rollercoaster of a week to say the least.

Originally Posted by S Landreth

Scientists have developed a simple test that can identify 18 early-stage cancers that experts say could represent a medical “gamechanger”.

now if only i wasn't 7,675,823rd on the waiting list

But if they were able to show that it does work (no questions) and start mass production, your wait time might drop a notch.

Originally Posted by S Landreth

Now US researchers have designed a test that analyses proteins in the blood and can pick up 18 early stage cancers, representing all main organs in the human body.

“These findings pave the way for a cost-effective, highly accurate, multi-cancer screening test that can be implemented on a population-wide scale.”

Originally Posted by S Landreth

But if they were able to show that it does work (no questions) and start mass production, your wait time might drop a notch.

indeed, the backlog is expected to get cleared in 16 years and 4 months, and that is if the "Junior" doctors don't continue striking and most of them don't emigrate to Australia

Originally Posted by malmomike77

now if only i wasn't 7,675,823rd on the waiting list

if you are talking about the NHS, then you need to know how to work the system to your advantage, by knowing what symptoms to exaggerate when consulting your GP in order for them to put you on the so called 2 week pathway, which as everybody knows is more like an 8 week pathway.

and the way to shorten subsequent delays is by having access to the phone numbers of consultants secretaries, appointment office back rooms and being able to put your case confidently, politely and in a completely non aggressive manner in order to move up the list and receive short notice cancellations.

as in any huge inefficient impersonal government bureaucracy manned by unthinking slothlike jobsworths, by using shrewdness, cunning, guile, humour, fawning, smarm and spiel, the system can often be worked to ones advantage.

Originally Posted by taxexile

if you are talking about the NHS, then you need to know how to work the system to your advantage, by knowing what symptoms to exaggerate when consulting your GP in order for them to put you on the so called 2 week pathway, which as everybody knows is more like an 8 week pathway.

and the way to shorten subsequent delays is by having access to the phone numbers of consultants secretaries, appointment office back rooms and being able to put your case confidently, politely and in a completely non aggressive manner in order to move up the list and receive short notice cancellations.

as in any huge inefficient impersonal government bureaucracy manned by unthinking slothlike jobsworths, by using shrewdness, cunning, guile, humour, fawning, smarm and spiel, the system can often be worked to ones advantage.

Smartest poster on the forum!

Originally Posted by britanicus123

Smartest poster on the forum!

or just go private

Originally Posted by nidhogg

In accordance with the Human Development Report 2021-22, the (HDI) rank of India is 132nd, among 191 countries. The HDR was titled as “Uncertain Times, Unsettled Lives: Shaping our Future in a Transforming World”

And yet this is a country with two aircraft carriers, a nuclear sub, nuclear weapons and just put a probe on the moon.

A cobra done bit my sister Aashvi.
(Wobbly's probe be on the moon)
Her long eight arms began to swell.
(Wobbly's probe be on the moon)
We can't pay no dowry bill.
(Wobbly's probe be on the moon)
Ten lives from now I'll be payin' still.
(Wobbly's probe be on the moon)
The chief jus' upped my rent las' night.
(Wobbly's probe be on the moon)
No beef, no soap, no Axe India
(Wobbly's probe be on the moon)

Cancer Is Striking More Young People, and Doctors Are Alarmed and Baffled

Meilin Keen was studying for the bar exam and preparing to move to New York City last June when she started throwing up blood.


Keen, 27 years old, learned days later that she has gastric cancer. She postponed the bar exam. Brain fog from chemotherapy made it hard to do her legal work.


Surgeons removed her stomach in December. Keen is coming to terms with all that means for her diet, her health, even her dating life. “That’s a fun icebreaker: I don’t have a stomach anymore,” she said.


Cancer is hitting more young people in the U.S. and around the globe, baffling doctors. Diagnosis rates in the U.S. rose in 2019 to 107.8 cases per 100,000 people under 50, up 12.8% from 95.6 in 2000, federal data show. A study in BMJ Oncology last year reported a sharp global rise in cancers in people under 50, with the highest rates in North America, Australia and Western Europe.


Doctors are racing to figure out what is making them sick, and how to identify young people who are at high risk. They suspect that changes in the way we live—less physical activity, more ultra-processed foods, new toxins—have raised the risk for younger generations.


“The patients are getting younger,” said Dr. Andrea Cercek, who co-directs a program for early-onset gastrointestinal cancer patients at Memorial Sloan Kettering Cancer Center in New York, where Keen was treated. “It’s likely some environmental change, whether it’s something in our food, our medications or something we have not yet identified.”

Actor Chadwick Boseman’s death at 43 from colon cancer in 2020 drew public attention to the rising prevalence of colorectal cancer in people under 50, a trend that first alarmed oncologists during the prior decade. They soon realized the crisis extended to some other cancers, including pancreatic, appendix, stomach and uterine.


“Colorectal cancer was the canary in the coal mine,” said Timothy Rebbeck, a cancer epidemiologist at the Dana-Farber Cancer Institute in Boston.


The U.S. cancer death rate has dropped by one-third since 1991, thanks to a plunge in smoking and better treatment. Screening to catch cancers earlier, including breast cancer, has helped, too.

MORE Cancer Is Striking More Young People, and Doctors Are Alarmed and Baffled - WSJ

New cancer diagnoses expected to hit record high this year

New cancer diagnoses in the U.S. are expected to top 2 million for the first time in 2024, driven in large part by an alarming increase in cancers among younger Americans, according to new American Cancer Society data.

Why it matters: There have been major improvements in cancer survival, but there's a worrying rise in some cancers at the same time doctors are trying to figure out why they're seeing more young patients with cancer.

What they're saying: This demographic shift comes with psychological, physical and financial burdens that are less common with older patients, experts say.

• Patients under 50 are more likely to be uninsured, juggling career and caregiving responsibilities, and face a higher lifetime risk of treatment-related side effects like second cancers.
• "It's overwhelming for anybody, but especially for these younger patients who are going on with their daily lives and then suddenly get this life-altering diagnosis and really don't know where to turn," Robin Mendelsohn, co-director of the Center for Young Onset Colorectal and Gastrointestinal Cancers at Memorial Sloan Kettering, told Axios.
• "Many feel alone because they're younger, their friends, many haven't had to deal with this."

Zoom in: The proportion of people 65 and older diagnosed with cancer dropped from 61% to 58% in the last 30 years, even as the size of that group increased. The proportion of those diagnosed between ages 50-64 was largely stable.

• "Notably, people aged younger than 50 years were the only one of these three age groups to experience an increase in overall cancer incidence during this time period," the ACS report said.
• Doctors don't know exactly what's behind the uptick in new cases and deaths among younger patients in many cases.

While new cases of colorectal cancer — the leading cause of cancer death in men under 50 and the second-leading cause of cancer death in women under 50 — have been declining among adults 65 and older, they've increased 1% to 2% annually in people younger than 55 since the mid-1990s.

• "Colorectal cancers are also presenting with more aggressive disease and larger tumors at diagnosis," ACS chief scientific officer William Dahut told Axios.
• Researchers are examining whether long-term factors like consumption of red meat or ultra-processed food, medication and vitamin use, and obesity are contributing to this shift.
• "Cancer obviously takes time to grow, especially colon cancer. So we think it's probably exposures from decades prior," Mendelsohn said.
• Preliminary MSK research found significant differences in the microbiomes of early-onset colorectal cancer patients compared with older ones. More research is needed but "this might be a signal," she said.

The big picture: The U.S. cancer death rate has been cut by a third in the last 30 years, partly due to improved screening, a sharp drop in smoking, and more effective treatments against certain cancers.

• But diagnoses have been increasing for some cancers, and there are strong racial and ethnic disparities in cancer deaths.

• New cases of prostate, liver, kidney and HPV‐associated oral cancers and melanoma each rose 2% to 3% annually between 2015 and 2019.
• Cases of breast, pancreas and uterine cancers also increased between .6% and 1% annually during that time.
• Black people were twice as likely to die from prostate, stomach and endometrial cancer compared with white people between 2016 and 2020. Mortality rates were also twice as high for Native American people for liver, stomach and kidney cancers in that same time frame.

The ACS projections exclude data from 2020, when the pandemic's first year led to a drop-off in cancer screenings.

• The largest delays in diagnoses appeared to be for cancers that tend to be less fatal or asymptomatic, according to ACS. For instance, there was a 16% drop for melanoma diagnosed in men and an 18% drop in thyroid cancer diagnosed in women that year.
• "The question of whether these delays lead to increased diagnosis of advanced‐stage disease and, ultimately, higher cancer mortality at the population level will be answered gradually over many years," the authors wrote.

Of note: There is some good news in the data. The decline in cancer mortality has resulted in more than 4 million fewer deaths in the U.S. since 1991.

• Still, the study projects cancer will kill nearly 612,000 people this year, up from a projected 609,820 in 2023.

The bottom line: Dahut said the study highlights the importance of timely screening, particularly among people with a strong family history of cancer or who are experiencing symptoms of the disease.

• "Most things, of course, won't be cancer. But if things seem abnormal, make sure you know you are satisfied by the workup," Dahut said.

• FDA Issues Warning of Cancer Risk Tied to CAR-T Therapies

The Food and Drug Administration is requiring companies that make specialized cancer therapies known as CAR-T to add a boxed warning that the treatments themselves may cause cancers.

The agency noted that the benefits still outweighed the risks of the therapy, which involves removing a type of white blood cells — T cells — and then genetically engineering them to create proteins called chimeric antigen receptors (CAR). Infused back into a patient’s blood, the engineered cells allow the T cells to attach to cancer cells and kill them.

But the therapies, which mostly treat blood cancers, including multiple myeloma, had already carried a warning for dangerous immune responses and for neurological risks. And the new warning follows reports of about 20 cases of secondary cancers that federal health officials and others have suspected were caused by CAR-T treatments, although more investigation may be needed to establish a definite link. The therapy has been used by an estimated 25,000 to 30,000 patients since it was first approved by the F.D.A. in 2017.

Cancer patients who receive CAR-T treatments tend to have few options left, and would be unlikely to alter course even with the new warning, said Dr. John DiPersio, an oncologist with Washington University in St. Louis.

“The risk of not doing this therapy for most patients who get it is rapid progression of their disease or certain death,” he said.

The F.D.A. raised concerns about the adverse effects of the treatments late last year.

In letters dated Jan. 19, the agency outlined the warnings to be included by some of the companies making CAR-T therapies, which had also been ordered to monitor patients for secondary cancers and report any to the F.D.A. The secondary cancers can lead to hospitalizations or death, the agency noted, requiring the drug companies to provide warnings on drug labels that secondary cancers “may present as soon as weeks following infusion, and may include fatal outcomes.”

The F.D.A. issued letters to these companies: Bristol-Myers Squibb, maker of Abecma; Juno Therapeutics, a Bristol-Myers Squibb Company, maker of Breyanzi; Janssen Biotech of Johnson & Johnson, maker of Carvykti; Novartis, of Kymriah; and Kite Pharma, of Yescarta.

Given the dire prognoses of the patients considering CAR-T therapies, Dr. DiPersio said, the new warning amounted to “much ado about nothing.” He said he hoped the news would not chill further investment or study of the treatments for other serious medical conditions. Some drugmakers are studying the use of CAR-T therapy to treat lupus, an autoimmune disease.

“We can’t create such a fearful environment that this approach is steered away from by companies and investigators because it’s thought to be too dangerous — because it’s not,” he said.

__________

• Breast cancer patients to benefit from new ‘highly targeted drug’

NICE has recommended a new ‘highly targeted drug’ for the treatment of some advanced types of breast cancer.

Around 300 people with advanced breast cancer who have inherited mutations in their BRCA1 or BRCA2 genes will soon be able to access talazoparib (Talzenna) on the NHS, which slows the cancer’s progression.

Initially, NICE decided not to recommend talazoparib due to drug’s cost. Now, Pfizer, the manufacturer, has offered an increased discount, allowing NICE to revisit its decision.

How effective is talazoparib?
Talazoparib has been recommended for adults with BRCA 1 or 2 mutated HER2-negative locally advanced or metastatic breast cancer after prior chemotherapy.

It is a PARP (poly adenosine diphosphate-ribose polymerase) inhibitor which works by shrinking or slowing the growth of certain types of cancer cells.

Talazoparib is taken as a once-daily tablet instead of chemotherapy, making it a more convenient treatment option for patients.

Evidence from a clinical trial showed that talazoparib increases how long people live without their cancer getting worse compared with chemotherapy. However, the trial did not show any difference in how long people live.

Until now, there were no targeted treatments for this type of advanced breast cancer available on the NHS and alternative treatment options are limited to chemotherapy (mainly taxanes) and best supportive care.

ICR welcomes recommendation of new treatment for advanced breast cancer

The Institute of Cancer Research (ICR) says it is “delighted” that NICE has made this new recommendation which has the ability to improve the quality of life of hundreds of breast cancer patients.

Professor Chris Lord, Professor of Cancer Genomics at The ICR, said: “This is a huge moment for the treatment of advanced forms of inherited breast cancer caused by mutations in the BRCA1 and BRCA2 genes. For the first time, NHS patients with this kind of breast cancer will be able to access a new drug which exploits the specific biology of their cancer. We are delighted that NICE have made this recommendation.

“Patients with advanced breast cancer have spent years campaigning for PARP inhibitors to be made available on the NHS. This decision will offer them a targeted treatment which can slow progression of their cancer and offer them extra months living with better quality of life, free from the side effects of chemotherapy. We are pleased that NICE and the manufacturer have reached an agreement to make talazoparib available at a price the NHS can afford.”

“It is wonderful news that UK patients will now be able to benefit from this highly targeted drug on the NHS,” added Professor Kristian Helin, Chief Executive of the ICR.

https://pavilionhealthtoday.com/fm/b...targeted-drug/

• Cervical cancer deaths rise among low-income Americans

Women in low-income regions of the U.S. are experiencing significantly more cases and deaths from cervical cancer despite an overall decline of the disease, according to a new study in the International Journal of Cancer.

Why it matters: The existence of an effective and widely available vaccine against human papillomavirus (HPV) — the source of virtually all cervical cancers — makes the disparity all the more troubling, researchers say.

The big picture: That takeaway was underscored by another study, published Thursday in the Journal of the National Cancer Institute, which found no cases of cervical cancer detected in women born between 1988 and 1996 who'd received the HPV vaccine when they were 12 or 13 years old.

• The World Health Organization has been seeking to eliminate cervical cancer globally, getting commitments from governments on immunization and screening targets, as well as awareness campaigns.

Details: A University of Texas MD Anderson Cancer Center-led research team found cervical cancer incidence was greatest among women in low-income regions of the U.S. in 2019, regardless of race or ethnicity. The highest overall incidence was in Hispanic women.

• Cases of cervical cancers that spread to distant parts of the body saw the biggest uptick among white women in low-income regions, increasing by 4.4% annually since 2007. Deaths have also increased in this group.
• Despite a declining incidence of cervical cancer among Black women, the study found the largest increase in deaths occurred in that cohort, at 2.9% annually since 2013.

• The study was drawn from more than 119,000 cases in the National Cancer Institute's registry between 2000 and 2019 and factored county-level household incomes.

More research is needed to understand what's driving these trends, but the analysis suggests that factors could include poor screening or an increase in the number of women who can't follow up or treat precancerous lesions once they're detected.

What they're saying: "Cervical cancer is almost entirely preventable," said co-senior author Jane Montealegre. "This continued upward trend calls for scaled-up efforts to eliminate disparities in cervical cancer prevention."

• Cancer rates set to rise 77 per cent by 2050

There are predicted to be more than 35 million cancer cases during 2050, up from the estimated 20 million in 2022, according to latest figures from the International Agency for Research on Cancer (IARC), a specialized branch of the UN World Health Organization (WHO).

The increase reflects both population ageing and growth, as well as changes to people’s exposure to risk factors. Tobacco, alcohol and obesity are key factors, along with air pollution.

Varying patterns

Richer countries are expected to have the greatest absolute increase in cancer, with an additional 4.8 million new cases predicted in 2050.

However, low and middle-income countries should see a higher proportional increase in cancer, while mortality is projected to almost double.

The estimates from the IARC’s Global Cancer Observatory are based on the best sources of data available from 185 countries and covers 36 different forms of cancer.

They were published alongside a WHO survey from 115 countries which showed that the majority do not adequately finance priority cancer and palliative care services as part of universal health coverage.

Common cancers globally

Ten types of cancer collectively comprised around two-thirds of new cases and deaths globally in 2022, the IARC said.

Lung cancer was the most commonly occurring form worldwide with 2.5 million new cases. It accounted for more than 12 per cent of all new cases and 18.9 per cent of deaths, 1.8 million, making it the leading cause of cancer death.

Female breast cancer ranked second in terms of occurrence, with 2.3 million cases, worldwide or 11.6 per cent, but accounted for 6.9 per cent of deaths.

Other commonly occurring cancers were colorectal, prostate and stomach cancer.

Colorectal cancer was the second leading cause of cancer death, followed by liver, breast and stomach cancer.

Cervical cancer was the eighth most commonly occurring cancer globally, the ninth leading cause of cancer death, and the most common cancer in women in 25 countries, many of which are in sub-Saharan Africa.

Inequalities and investment

The IARC estimates - issued ahead of World Cancer Day on 4 February - also revealed striking inequalities, particularly in breast cancer.

One in 12 women in richer countries will be diagnosed with the disease in their lifetime and one in 71 will die of it, the agency said. However, although only one in 27 women in poorer countries will receive a positive breast cancer diagnosis, one in 48 will die.

These women “are at a much higher risk of dying of the disease due to late diagnosis and inadequate access to quality treatment,” said Dr. Isabelle Soerjomataram, Deputy Head of the Cancer Surveillance Branch at IARC.

The WHO survey also revealed significant global inequities in cancer services. For example, higher income countries were up to seven times more likely to include lung cancer-related services in their health benefits packages.

“WHO, including through its cancer initiatives, is working intensively with more than 75 governments to develop, finance and implement policies to promote cancer care for all,” said Dr Bente Mikkelsen, Director of its Department of Noncommunicable Diseases, underlining the need for greater investment.

I hate reading this thread.

Because, well, sad news.

My mate's wife has been diagnosed with breast cancer.

She's only early 40s.

The docs say they've caught it early though and they are quite optmistic.

Last time they said that it was for another's pal's mum- she died.

I have that same uneasy feeling I had back then when my pal told me his mum had the big C.

Hope I'm wrong.

Originally Posted by hallelujah

I hate reading this thread.

Something else you’re going to hate. Although I believe you’ve heard it before.

Originally Posted by S Landreth

The increase reflects both population ageing and growth, as well as changes to people’s exposure to risk factors. Tobacco, alcohol and obesity are key factors, along with air pollution.

Obesity and Cancer | CDC

How does obesity cause cancer? | Cancer Research UK

She's not fat.

And neither am I.

You weird internet kunt.

• FDA approves first cell therapy to treat aggressive forms of melanoma

The Food and Drug Administration has approved a novel type of cancer therapy to treat aggressive forms of melanoma using immune system cells from a patient's tumor.

The treatment, called Amtagvi, was developed by Iovance Biotherapeutics, a biotech company based in San Carlos, Calif.

It is intended for patients whose melanoma cannot be removed with surgery or has spread to other parts of the body.

"The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options," Dr. Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, said in a statement announcing the approval on Friday.

Melanoma develops when the skin cells that produce pigment start to grow out of control, according to the American Cancer Society. A major risk factor is exposure to ultraviolent light, which typically comes from the sun or tanning beds.

The tumor is easy to treat when detected early. But if it's not removed in time, melanoma can quickly spread to other parts of the body.

Amtagvi is designed to fight off advanced forms of melanoma by extracting and replicating T cells derived from a patient's tumor. T cells are part of the immune system. While they can typically help fight cancer, they tend to become dysfunctional inside tumors.

The newly approved medicine is similar to CAR-T, which is mainly used to treat blood cancers. Amtagvi is the first cell therapy approved by the FDA for solid tumors.

Amtagvi was fast-tracked through the FDA's accelerated approval pathway, a program to give patients with urgent, life-threatening illnesses early access to promising treatments.

Although Amtagvi was given the greenlight, Iovance Biotherapeutics said it is in the process of conducting an additional trial to confirm the treatment's efficacy, which is required by the FDA.

Melanoma only accounts for 1% of all skin cancer cases but it has been linked to a "significant number" of cancer-related deaths, according to the FDA.

The American Cancer Society estimates that in 2024, about 100,000 new cases of melanoma will be diagnosed and about 8,000 people will die from the skin cancer.

________

• FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma | FDA

Today, the U.S. Food and Drug Administration approved Amtagvi, the first cellular therapy indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor).

“Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “The approval of Amtagvi represents the culmination of scientific and clinical research efforts leading to a novel T cell immunotherapy for patients with limited treatment options.”

Melanoma is a form of skin cancer that is often caused by exposure to ultraviolet light, which can come from sunlight or indoor tanning. Although melanomas only represent approximately 1% of all skin cancers, they account for a significant number of cancer-related deaths. Melanoma can spread to other parts of the body if not detected and treated early, resulting in metastatic disease.

Treatment for unresectable or metastatic melanoma may include immunotherapy using PD-1 inhibitors, which are antibodies targeting certain proteins in the body to help the immune system fight off cancer cells. In addition, drugs targeting the BRAF gene, which helps with managing the growth and functioning of cells, may be used for treating melanoma associated with BRAF gene mutations. Those patients whose melanoma has progressed with these therapies have a high unmet medical need.

Amtagvi is a tumor-derived autologous T cell immunotherapy composed of a patient’s own T cells, a type of cell that helps the immune system fight cancer. A portion of the patient’s tumor tissue is removed during a surgical procedure prior to treatment. The patients’ T cells are separated from the tumor tissue, further manufactured and then returned to the same patient as a single dose for infusion. This is the first FDA-approved tumor-derived T cell immunotherapy.

“Melanoma is a life-threatening cancer that can cause devastating impacts to affected individuals, with a significant risk of metastasizing and spreading to other areas in the body,” said Nicole Verdun, M.D., director of the Office of Therapeutic Products in CBER. “Today’s approval reflects the FDA’s dedication and commitment to the development of innovative, safe and effective treatment options for cancer patients.”

Amtagvi was approved through the Accelerated Approval pathway, under which the FDA may approve drugs for serious or life-threatening illnesses or conditions where there is an unmet medical need and the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients (improving how patients feel or function, or whether they survive longer). This pathway generally gives patients the opportunity for earlier access to a promising therapy while the company conducts further trials to verify the predicted clinical benefit. A confirmatory trial is ongoing to verify Amtagvi’s clinical benefit.

The safety and effectiveness of Amtagvi was evaluated in a global, multicenter, multicohort clinical study including adult patients with unresectable or metastatic melanoma who had previously been treated with at least one systemic therapy, including a PD-1 blocking antibody, and if positive for the BRAF V600 mutation, a BRAF inhibitor or BRAF inhibitor with an MEK inhibitor. Effectiveness was established based on objective response rate to treatment and duration of response (measured from the date of confirmed initial objective response to the date of progression, death from any cause, starting a new anti-cancer treatment or discontinuation from follow-up, whichever came first). Among the 73 patients treated with Amtagvi at the recommended dose, the objective response rate was 31.5%, including three (4.1%) patients with a complete response and 20 (27.4%) patients with a partial response. Among patients who were responsive to the treatment, 56.5%, 47.8% and 43.5% continued to maintain responses without tumor progression or death at six, nine and 12 months, respectively.

Patients treated with Amtagvi may exhibit prolonged severe low blood count, severe infection, cardiac disorder, or develop worsened respiratory or renal function or have fatal treatment-related complications. A Boxed Warning is included in the label containing information about these risks. Patients receiving this product should be closely monitored before and after infusion for signs and symptoms of adverse reactions. Treatment should be withheld or discontinued in the presence of these symptoms, as indicated.

The most common adverse reactions associated with Amtagvi included chills, fever, fatigue, tachycardia (abnormally fast heart rate), diarrhea, febrile neutropenia (fever associated with a low level of certain white blood cells), edema (swelling due to buildup of fluid in body tissues), rash, hypotension, hair loss, infection, hypoxia (abnormally low oxygen levels in the body) and feeling short of breath.

Amtagvi also received Orphan Drug, Regenerative Medicine Advanced Therapy, Fast Track, and Priority Review designations.

The FDA granted the approval of Amtagvi to Iovance Biotherapeutics Inc.

Thai govt hospitals seem hit and miss. MIL was told she had liver cancer stage 3 two months ago, sent to another hospital. They says it's just a small spot and book her in for surgery, when her daughter asked if it could be put off until after her wedding last week they said no better get it done ASAP. surgery was for two weeks ago. Day before they called and say it's so small not worth surgery and will put her on chemo, still waiting for the pills!

wishing her well