Readout Newsletter: Keytruda, IRA, Pfizer, psychedelics

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

Good morning. I’m in New York this week with my colleague Adam Feuerstein for the Cantor Fitzgerald Healthcare Conference. Say hi if you’re there and you see us!

Onto the biotech news today.

Ten years of Keytruda brings celebration and debate

Ten years ago, a new type of cancer treatment reached the market — immunotherapies like Bristol Myers Squibb’s Opdivo and Merck’s Keytruda that rouse the body’s own immune cells to attack tumors. They were at first approved for melanoma, and then for many other cancers over the years.

At this year’s European Society for Medical Oncology annual meeting, the field celebrated this milestone, with researchers showing years of accrued data to demonstrate how the drugs are helping patients and saving lives over the long term.

But these results have also prompted a once-unthinkable debate about how and when to declare some patients cured. There were reminders, too, that these drugs are not magic bullets, as there are still some patients who don’t respond to these therapies.

Who’s who in the growing field of psychedelics

From my colleague Meghana Keshavan: The psychedelics industry is rich with some rather colorful characters. We’ve compiled a list of 11 who are helping shape the field — from scientists to financiers to company executives.

These drugs could help unlock a new paradigm in mental health treatment, if they’re wielded correctly, and deemed scientifically sound.

Among the names: Robin Carhart-Harris, Christian Angermayer, and Srinivas Rao. Honorable mention goes to Sam Clark of Terran Biosciences, who will surely make a similar list in the not-so-distant future.

Pfizer probes Medicare’s plan for digital treatments

After Medicare issued a proposal in July to start paying for some mental health apps, it wasn’t just startups that took notice. Some of the largest pharma and health care companies in the country weighed in on the proposal during the comment period.

Among them was Pfizer, which supports the proposal, but argued that it was “unduly restrictive.” As written, the proposal would cover just seven products currently cleared under an narrow FDA regulation covering computerized behavioral therapy. This, Pfizer points out, would exclude legally marketed mental health treatments that are authorized under other pathways or are not subject to FDA regulations but may nevertheless be effective.

Pfizer has not launched any digital treatments or made its plans outwardly clear yet, but in 2022, it hired Edward Cox, a veteran executive of the digital therapeutics industry, as head and general manager of digital health and medicines.

Key Senate aide behind drug pricing policy to leave

The staffer who drafted much of the drug pricing portion of the Inflation Reduction Act is leaving the Senate Finance Committee next month, my colleagues exclusively report.

The aide, Shawn Bishop, has played a major role behind the scenes on some of the most impactful health care laws of the past 15 years. Before working on the sections of the IRA that allow Medicare to negotiate drug prices, she was closely involved with key pieces of the Affordable Care Act.

Read more from STAT’s John Wilkerson and Rachel Cohrs Zhang.

FDA formalizes protocol for international cancer trials

The FDA yesterday issued draft guidance on oncology clinical trials, taking the first steps toward formalizing a position that it’s long expressed — wanting trials to range beyond single countries such as China.

The FDA’s oncology chief Rick Pazdur had for a while opened the door to Chinese cancer drugs, but then a few years ago, in an about-face, adopted a more restrictive view, frustrating U.S. pharma executives at the time. At a STAT event at ASCO this year, Pazdur reiterated his position, saying he wants companies to conduct trials in multiple regions and enroll a diverse population of patients.

When announcing the new draft guidance, the FDA said it encourages companies to pursue multiregional trials but also stressed that the data should be applicable to U.S. patients. “The new draft guidance, when finalized, will not only support the agency’s review of data generated from multiregional clinical trials, but also help sponsors improve the generalizability and applicability of results from these trials to the U.S. population and to U.S. medical practice,” Pazdur said in a statement.

This draft guidance comes after Summit Therapeutics recently reported detailed data showing that its experimental lung cancer therapy beat Merck’s blockbuster Keytruda in a late-stage trial. That study was conducted only in China, though, and Summit plans to start a global trial next year.