October 16, 2024

A controversial approval for Novocure's device

From my colleague Adam Feuerstein: The FDA yesterday expanded the approval of Novocure's Optune electrical field medical device to include the treatment of metastatic non-small cell lung cancer.

The new marketing clearance is based on the results of a Phase 3 study, called LUNAR, that showed Optune prolonged median overall survival by 3.3 months in patients with lung cancer that progressed following initial chemotherapy.

The study achieved its primary goal with statistical significance, but when the data were presented in 2023, some lung cancer experts said the results were uninterpretable and outside current clinical practice because nearly 70% of participants hadn't received initial treatment with an immune checkpoint inhibitor such as Merck's Keytruda.

The Optune device, which is also referred to as tumor treating fields, consists of four wired patches that are applied with skin adhesive to the upper body, surrounding the lungs. When connected to an external, battery-powered generator, the patches create an electrical field tuned to interfere with the cell division of tumor cells, while sparing healthy cells. Patients are instructed to wear the device for up to 18 hours per day.

Optune was approved initially to treat certain types of brain tumors. In lung cancer, it will be sold under the brand name Optune Lua.

obesity

Why the FDA chief is impressed by GLP-1 drugs

FDA Commissioner Robert Califf considers GLP-1 treatments to be a "breakthrough class of drugs."

In an interview about the state of cardiovascular health in the U.S., Califf said that all the evidence so far for GLP-1s "is overwhelmingly good." He sees promise in using them not only for weight loss, but also for cardiovascular health and to treat MASH and addictive behaviors.

At the same time, though, he hinted at how the drugs aren't addressing the root causes of high obesity rates in the U.S.

"I have this recurrent thought that my great-grandkids will read that there was once a country called the U.S.A. where we used overwhelming manipulation of food and advertising to create an enormously obese population. And our solution to it was to invent a class of drugs that cost $20,000 a year to try to counteract it," he said. "And they would say, 'What kind of country is that? Why didn't you just eat good food to start with and not end up like that?'"

opinion

What Bayer's COO wants to see in election platforms

As part of an ongoing series ahead of Election Day, STAT's First Opinion section has reached out to biopharma executives to ask their thoughts on how the industry is being portrayed on the campaign trail.

Bayer CEO Sebastian Guth weighed in today. The four main policy points he would like to see are: reforming the role of pharmacy benefit managers, fixing the 340B program so that patients experience savings, resisting price setting, and safeguarding intellectual property.

podcast

How Martin Shkreli got Mark Cuban into the drug world

If it weren't for "Pharma Bro" Martin Shkreli, Mark Cuban may not have gone into the drug business.

That's what Cuban said in this week's episode of the "First Opinion Podcast." About the time Shkreli was heading to prison, Cuban first started speaking with Alex Oshmyansky, his eventual co-founder of Mark Cuban Cost Plus Drugs.

When Cuban asked Oshmyansky to explain how Shkreli was able to radically raise the price of Daraprim, the answer startled him. "It became quickly obvious that the pharmacy industry is as opaque as any industry … I've ever been involved with, and that the easiest way to counteract opacity is transparency," Cuban said on the podcast.

Listen here to learn more about the origin story of Cuban's company and his frustrations with the entire health care system.

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