Novocure, Bayer, Martin Shkreli updates

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Good morning. I arrived in Boston for our annual STAT summit, and I successfully convinced my colleague Adam Feuerstein to bake me a cheesecake.

A controversial approval for Novocure’s device

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

The new marketing approval is based on results from a Phase 3 trial called LUNAR, which showed that Optune extended median overall survival by 3.3 months in patients with lung cancer that progressed after initial chemotherapy.

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

The Optune device, also called tumor treatment fields, consists of four wired patches that are applied with skin glue to the upper body, around the lungs. When connected to an external, battery-powered generator, the patches create an electrical field tuned to disrupt cell division of tumor cells while sparing healthy cells. Patients are instructed to wear the device for a maximum of 18 hours per day.

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

Why the head of the FDA is impressed with GLP-1 drugs

FDA Commissioner Robert Califf considers GLP-1 treatments a “breakthrough class of drugs.”

In an interview about the state of cardiovascular health in the US, 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, however, he hinted that the drugs are not addressing the root causes of high obesity rates in the US.

“I have the recurring thought that my great-grandchildren will read that there was once a country called the USA where we used overwhelming manipulation of food and advertising to create a massively obese population. And our solution to this was to invent a class of drugs that cost $20,000 a year to combat this,” he said. ‘And they said, ‘What kind of country is that? Why didn’t you just eat well in the beginning and not end up like that?’”

Read more from STAT’s Liz Cooney.

What Bayer’s COO wants to see on election platforms

As part of an ongoing series leading up to Election Day, STAT’s First Opinion section has reached out to biopharmaceutical industry executives to ask their opinions on how the industry is being portrayed on the campaign trail.

Bayer CEO Sebastian Guth weighed in today. The four key policy items he would like to see are: reforming the role of pharmacy benefit managers, establishing the 340B program so patients can experience savings, resisting price gouging and protecting intellectual property.

Read more.

How Martin Shkreli brought Mark Cuban into the drug business

Without ‘Pharma Bro’ Martin Shkreli, Mark Cuban might not have gotten into the drug trade.

Cuban said on this week’s episode of the “First Opinion Podcast.” Around the time Shkreli was headed to prison, Cuban first started talking to Alex Oshmyansky, his eventual co-founder of Mark Cuban Cost Plus Drugs.

When Cuban asked Oshmyansky to explain how Shkreli was able to radically increase the price of Daraprim, the answer shocked him. “It quickly became clear that the pharmaceutical industry is as opaque as any industry I have ever been involved in, and that the easiest way to combat 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 healthcare system.

Read more

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