Stage 3 Cancer: Definition, Diagnosis, Treatment, Prognosis

F.D.A. Approves Drug For Persistently Deadly Form Of Lung Cancer

The Food and Drug Administration on Thursday approved an innovative new treatment for patients with a form of lung cancer. It is to be used only by patients who have exhausted all other options to treat small cell lung cancer, and have a life expectancy of four to five months.

The drug tarlatamab, or Imdelltra, made by the company Amgen, tripled patients' life expectancy, giving them a median survival of 14 months after they took the drug. Forty percent of those who got the drug responded.

After decades with no real advances in treatments for small cell lung cancer, tarlatamab offers the first real hope, said Dr. Anish Thomas, a lung cancer specialist at the federal National Cancer Institute who was not involved in the trial.

"I feel it's a light after a long time," he added.

Dr. Timothy Burns, a lung cancer specialist at the University of Pittsburgh, said that the drug "will be practice-changing."

(Dr. Burns was not an investigator in the study but has served on an Amgen advisory committee for a different drug.)

The drug, though, has a side effect that can be serious — cytokine release syndrome. It's an overreaction of the immune system that can result in symptoms like a rash, a rapid heartbeat and low blood pressure.

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Health News Roundup: US FDA Approves Amgen Drug For Small Cell Lung Cancer; US Unveils Proposal To Ease Restrictions On Marijuana And More

Following is a summary of current health news briefs.

EU regulator scraps approval for pregnancy drug over cancer risk

The European Medicines Agency (EMA) on Friday recommended scrapping approval for a drug used to prolong gestation, citing a "possible but unconfirmed" risk of cancer. The EU health regulator's Pharmacovigilance Risk Assessment Committee (PRAC), which monitors drug-related side effects, considered new studies in its review that showed the treatment, 17-hydroxyprogesterone caproate (17-OHPC), was not effective in preventing premature birth.

Moderna wins COVID shot patent case against Pfizer-BioNTech in Europe

Moderna said on Friday the European Patent Office had upheld the validity of one of the company's key patents, a win in an ongoing COVID-19 vaccine dispute with Pfizer and BioNTech.

The company has been locked in a legal battle with Pfizer-BioNTech over their COVID shot Comirnaty after suing them in 2022 for allegedly copying its mRNA technology.

GSK raises $1.5 billion from offloading Haleon stake at a discount

GSK has raised 1.25 billion pounds ($1.52 billion) from selling its entire remaining stake in consumer healthcare firm Haleon, the British drugmaker said on Friday. GSK sold around 385 million shares at 324 pence apiece, amounting to a 4.2% stake in Haleon. The company was formed in a merger of GSK and Pfizer's consumer healthcare businesses in 2019.

Ontario reports first death from measles in over a decade

An Ontario child under the age of five has died of measles, the first such case in the Canadian province in more than a decade, according to the provincial health agency. The child required hospitalization and was not vaccinated against the highly infectious respiratory virus, Public Health Ontario (PHO) said in a statement on Thursday, without specifying when or where the child died, or their actual age.

Americans divided as Supreme Court weighs abortion pill access, Reuters/Ipsos poll finds

Americans are divided on whether women should have to see a doctor in person before receiving abortion pills, a new Reuters/Ipsos poll found, as the U.S. Supreme Court weighs whether to reimpose that restriction on medication abortion. But broad bipartisan majorities opposed the idea of allowing states with abortion bans in place to block access to the procedure in certain emergency cases when it is needed to protect the mother's health, at issue in another case before the court.

US FDA approves Amgen drug for small cell lung cancer

The U.S. Food and Drug Administration on Thursday granted accelerated approval to Amgen's tarlatamab, a targeted immunotherapy for adults in the advanced stages of hard-to-treat small cell lung cancer that has worsened despite chemotherapy. The drug, marketed under the name Imdelltra, is part of Amgen's pipeline of bispecific antibodies designed to attach to a cancer cell and an immune cell, bringing them together so that the body's immune system can kill the cancer.

Properly cooked hamburgers pose no bird flu risk, US study finds

No bird flu virus was found after cooking ground beef to medium to well done, the U.S. Department of Agriculture said in a briefing on Thursday after conducting a study as it addresses concerns over an outbreak of the disease in dairy cattle. The findings, in which scientists injected high levels of an H5N1 bird flu virus surrogate into ground beef, indicate that properly cooking hamburgers to a temperature of about 145 to 160 degrees Fahrenheit (63 to 71 degrees Celsius) keeps them safe for consumers.

US unveils proposal to ease restrictions on marijuana

The U.S. Justice Department on Thursday unveiled a historic proposal to ease restrictions on marijuana, a rule that if enacted would also enable more research on its medicinal benefits. The proposal, first announced in April, would reclassify cannabis from a so-called schedule one drug to a schedule three. Schedule one drugs, such as heroin, are considered highly addictive with no medical benefits, while schedule three drugs are considered to have a moderate to low potential for physical and psychological dependence.

Obesity and high blood sugar play ever growing role in ill-health, study shows

Obesity, high blood sugar and high blood pressure among other metabolic issues now lead to almost 50% more years of healthy life lost to either disease or premature death than in 2000, a major international study showed on Thursday. Over the same period, the number of years lost due to factors associated with undernutrition for mothers and children, such as stunting or wasting, dropped by 71.5%.

Investors demand clarity from Fresenius over dialysis group FMC

Investors demanded more clarity from German healthcare group Fresenius SE on Friday regarding its plans to cede strategic control over dialysis group Fresenius Medical Care. "The volatility at Fresenius Medical Care seems to repeatedly overshadow the recent positive operating developments at Fresenius and is also deterring many potential shareholders from investing in Fresenius," said Hendrik Schmidt, corporate governance expert at fund manager DWS.

(With inputs from agencies.)

FDA Expedites Review Of Petosemtamab In Head And Neck Cancer

A breakthrough therapy designation was granted to petosemtamab by the FDA to treat patients with recurrent or metastatic head and neck cancers.

A novel treatment for patients with head and neck cancers has received a breakthrough therapy designation from the FDA.

The Food and Drug Administration (FDA) granted a breakthrough therapy designation for petosemtamab, a novel treatment for patients with recurrent or metastatic head and neck cancers, a news release stated.

Specifically, the petosemtamab designation is for patients with head and neck cancers who experienced disease progression after platinum-based chemotherapy and a PD-1 or PD-L1 antibody. PD-1 and PD-L1 are proteins targeted by certain immunotherapy drugs. They play a role in helping cancer hide from the immune system, as defined by the National Cancer Institute.

According to the news release from Merus, the manufacturing company of petosemtamab, the FDA's decision to grant a breakthrough therapy came after a fast track designation in August 2023.

A breakthrough therapy designation is "designed to expedite the development and review of drugs" used to treat serious conditions, as the FDA defines. A fast track designation facilitates the development and expedites the review of drugs, the FDA explains, to treat serious conditions with unmet needs.

Petosemtamab, the manufacturer defines, is a monoclonal antibody drug that binds to the epidermal growth factor receptor (EGFR) to help the immune system kill cancer cells.

"We are excited and encouraged to receive BTD for petosemtamab which further validates its potential to become a new standard of care for patients with previously treated [head and neck cancers]," Ashley Pereira, SVP of regulatory affairs at Merus, said in the news release.

The breakthrough therapy designation of petosemtamab is based on an ongoing phase 1/2 trial, the release stated.

Approximately 360 patients were assigned into two treatment arms to receive either petosemtamab alone or petosemtamab plus Keytruda (pembrolizumab), the ClinicalTrials.Gov listing noted. Cancer types included advanced or metastatic solid tumors, such as colorectal cancer, gastric cancer, gastroesophageal-junction cancer, non-small cell lung cancer and head and neck cancers.

During the second half of 2024, the manufacturing company plans to update information about efficacy (how well the drug works), durability (ability to delay disease worsening) and safety, the release reported.

Particularly, researchers on the trial are aiming to identify several primary outcomes, according to the listing. Of note, they are evaluating the number of patients who have dose-limiting toxicities, meaning the number of patients who experience side effects from treatment during dose escalation. An observation of side effect severity from treatment will also be evaluated, the listing stated.

Other primary outcomes that will be measured include safety and tolerability based on the respective treatments, the listing noted. Instances of abnormal readings and results, severity of side effects from treatments and treatment discontinuations based on side effects. The time frame of these safety evaluations is six to 12 months, ClinicalTrials.Gov noted.

"We look forward to continue constructive conversations with the FDA as we move forward in our plan to initiate a phase 3 trial in previously treated [head and neck squamous cell carcinoma] mid-2024 and prepare for a potential phase 3 trial evaluating the combination of petosemtamab and [Keytruda] in previously untreated patients," Pereira said.

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