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New targeted drug may help lung cancer patients

U.S. regulators have approved the first medicine for patients with the most common type of lung cancer whose tumors have a genetic mutation long considered untreatable with drugs.

The Food and Drug Administration in May said it has approved Amgen’s drug Lumakras to treat non-small cell lung cancer with the mutation in patients who have worsened after initial treatment with at least one other drug. Each year, about 13,000 U.S. patients are diagnosed with this cancer and mutation.

This is the first targeted therapy for tumors with a so-called KRAS mutation, the FDA noted. This type of mutation occurs in genes that help regulate cell growth and division. The mutation is involved in many cancer types.

“Today’s approval represents a significant step toward a future where more patients will have a personalized treatment approach,” Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said in a statement.

Amgen said Lumakras, also known as sotorasib, will cost $17,900 per month, though most patients will pay less, depending on health insurance and other factors. Lung cancer is the most common cancer type and is the leading cause of cancer deaths in the U.S.

The agency also approved diagnostic tests from two companies that can determine if patients have the specific mutation, known as KRAS G12C, targeted by the drug.

Amgen and other drugmakers are working to develop several medicines designed to attack tumors with KRAS mutations.

“KRAS has challenged cancer researchers for more than 40 years,” Dr. David M. Reese, Amgen’s head of research and development, said in a statement.

The FDA approved the drug on an accelerated schedule, based only on early study results, because of its potential and the lack of options for these patients. It is requiring further testing to confirm the drug’s benefit.

In a study including 124 patients, 36% had their tumors shrink or disappear. Improvements lasted for six months or longer for nearly 60% of those who benefited.

Common side effects included diarrhea, joint and muscle pain, fatigue and liver damage. The FDA said the drug should be discontinued if patients develop liver damage or a type of lung disease.

—AP

FDA stops use of heart pump tied to deaths

U.S. health regulators warned surgeons in June to stop implanting a heart pump made by Medtronic due to power failures recently tied to cases of stroke and more than a dozen deaths.

Medtronic said it would stop selling its Heartware assist device, which is intended to boost blood circulation in patients with heart failure.

Recent company data showed the device can unexpectedly stop working and sometimes fail to restart, the Food and Drug Administration said. The company said it hasn’t been able to pinpoint the root cause in every case.

Surgeons can use implants from other manufacturers, the FDA said in a memo to physicians.

About 4,000 people worldwide currently have the Medtronic device, roughly half of them in the U.S. For those patients, the agency said U.S. doctors should contact the company for the latest guidance on managing the device, which includes managing blood pressure.

The FDA said Medtronic halted sales after reviewing 100 reports of power failures with the device, which led to 14 patient deaths and 13 patients having it removed.

The company previously issued recalls on some Heartware devices and components used when implanting it. In December, the company warned about power failures or delayed restarts with three lots.

The company said patients should not automatically have the device removed. Taking out recalled heart implants has to be carefully weighed against the potential risks of surgery. The company said it is preparing a guide for managing patients “who may require support for many years.”

—AP

FDA approves obesity drug that cut weight by 15%

Regulators in June said a new version of a popular diabetes medicine could be sold as a weight-loss drug in the U.S.

The Food and Drug Administration approved Wegovy, a higher-dose version of Novo Nordisk’s diabetes drug semaglutide, for long-term weight management.

In company-funded studies, participants taking Wegovy had average weight loss of 15%, about 34 pounds (15.3 kilograms). Participants lost weight steadily for 14 months before plateauing. In a comparison group getting dummy shots, the average weight loss was about 2.5%, or just under 6 pounds.

“With existing drugs, you’re going to get maybe 5% to 10% weight reduction, sometimes not even that,” said Dr. Harold Bays, medical director of the Louisville Metabolic and Atherosclerosis Research Center. Bays, who is also the Obesity Medicine Association’s chief science officer, helped run studies of the drug.

In the U.S., more than 100 million adults — about 1 in 3 — are obese. Dropping even 5% of one’s weight can bring health benefits, such as improved energy, blood pressure, blood sugar and cholesterol levels, but that amount often doesn’t satisfy patients who are focused on weight loss, Bays said.

Bays said Wegovy appears far safer than earlier obesity drugs that “have gone down in flames” over safety problems. Wegovy’s side effects were gastrointestinal problems, including nausea, diarrhea and vomiting. Those usually subsided, but led about 5% of study participants to stop taking it.

Wegovy (pronounced wee-GOH’-vee) is a synthesized version of a gut hormone that curbs appetite. Patients inject it weekly under their skin. Like other weight-loss drugs, it’s to be used along with exercise, a healthy diet and other steps like keeping a food diary.

The Danish company hasn’t disclosed Wegovy’s price but said it will be similar to the price of its Saxenda, a weight-loss drug injected daily that now typically costs more than $1,300 per month without insurance.

Phylander Pannell, 49, of Largo, Maryland, joined a patient study after cycles of losing and then regaining weight. She said she received Wegovy, worked out several times a week and lost 65 pounds over 16 months.

“It helped curb my appetite, and it helped me feel full faster,” Parnell said. “It got me on the right path.”

Shortly after she finished the study and stopped receiving Wegovy, she regained about half the weight. She’s since lost much of that, started exercise classes and bought home exercise equipment. She’s considering going back on Wegovy after it’s approved. Novo Nordisk also is developing a pill version.

—AP