• Earnings season rolls on, with Roche and Argenx reporting this morning.
• Verdiva Bio, which is working on obesity drugs, has hired Steve Marso as chief medical officer. He was previously CMO at Metsera, the obesity-focused biotech that Pfizer acquired last year.

regulation

FDA panel will tackle the peptide issue

Americans are increasingly using synthetic peptides — despite scant evidence of their safety or effectiveness. Today and tomorrow, an FDA advisory committee will mull whether compounding pharmacies should be allowed to manufacture seven peptides, in particular. This could mean a clash between career FDA scientists, newly appointed panelists with ties to prescribing peptides, and an HHS leadership that generally supports broader access to these substances, STAT’s Sarah Todd and Lizzy Lawrence write.

Although regulating the compounding of peptides could steer patients away from an unregulated gray market, there’s concern that expanding access to them without stronger clinical evidence could legitimize therapies whose risks remain poorly understood.

“The key public health question is whether these products should become more widely available before that evidence exists,” said Jason Nagata, an associate professor of pediatrics at University of California San Francisco who recently co-authored an editorial for JAMA on peptides’ regulatory gaps. “Expanding compounding access without a stronger scientific foundation could inadvertently confer a sense of medical legitimacy on products whose safety and efficacy remain largely unknown.”

Read more.

cancer

FDA accepts RevMed's cancer drug submission

The FDA has accepted Revolution Medicines’ new drug application for daraxonrasib, moving the company a step closer to the expected approval of its therapy for metastatic pancreatic cancer. The filing is backed by a Phase 3 study that showed the drug resulted in significant improvements in overall survival and progression-free survival over standard chemotherapy, along with delayed worsening of pain and quality of life.

The application is being reviewed through the FDA Commissioner’s National Priority Voucher pilot, an expedited program that could shorten the review timeline.

cancer

GSK gets first-ever lung cancer approval

The FDA has approved GSK's Jideytro for a type of non-small cell lung cancer, giving the U.K. firm its first lung cancer drug as it seeks to build out its oncology portfolio.

Jideytro, also known as zidesamtinib, came to GSK through its acquisition of Nuvalent, a deal worth $10.6 billion that was only announced last month. The approval, which came ahead of the FDA target date by nearly two months, covers patients with advanced or metastatic tumors with ROS1 mutations who previously tried an ROS1 kinase inhibitor. Zidesamtinib is also being explored as a first-line treatment.

"The rapid progression of Jideytro from development to approval reflects both the strength of the underlying science and the urgent need for additional effective and tolerable treatments for ROS1-positive lung cancer," GSK Chief Scientific Officer Tony Wood said in a statement. "Today's approval provides an important new option for these patients and supports our strategy to acquire assets with validated targets that could meaningfully improve standards of care.”

GSK, which did not immediately say what the drug's U.S. list price would be, returned to oncology in recent years after previously leaving the field. It has other lung cancer drug candidates in trials.