Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on a cuppa stimulation. Our choice today is old-fashioned vanilla. Feel free to join us. Remember, no prescription is required. Meanwhile, here are some tidbits to help you along. Best of luck accomplishing your goals today, and of course, do keep in touch. …
Metastatic pancreatic cancer patients who received a targeted pill from Revolution Medicines lived nearly twice as long as patients who received chemotherapy, a striking result in a notoriously deadly and intractable malignancy, STAT reports. Patients who took the daily pill, called daraxonrasib, lived a median of 13.2 months, compared to 6.7 months for patients who received chemotherapy. The company plans to use the data to apply for approval, although it did not say when. Revolution received a Commissioner’s National Priority Review Voucher, part of a controversial U.S. Food and Drug Administration program to review drugs in just one to two months, so the pill could be considered quickly. The pill blocks a notorious group of genes called RAS. Mutant forms of the protein are present in roughly 30% of all human cancers, including over 90% of pancreatic cancers. But nearly all efforts to curb it have failed.
The FDA — again — an experimental treatment for advanced skin cancer developed by Replimune, STAT notes. The treatment, an engineered virus designed to rev up the immune system against melanoma, has been a flashpoint in a simmering debate over shifting standards at the agency. In October, Replimune resubmitted the drug and sought accelerated approval. A spokesperson said the company added new analyses on the drug’s mechanism of action and on how patients fared relative to prior treatment with an approved immunotherapy. A rejection letter posted by the agency noted that reviewers were concerned that the effects of Replimune’s drugs couldn’t be properly teased out, because the virus is given alongside Opdivo, Bristol Myers Squibb’s approved PD-1 checkpoint inhibitor.
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