Questions about the FDA's fast-tracking AI review

Calling it a “historic first,” FDA chief Marty Makary ordered every review decision at the agency to start using a new generative-AI system and hit “full implementation” by June 30, promising it will improve productivity — perhaps giving some workers a much-needed reprieve given the extent of layoffs that have hit the agency.

“We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process,” Makary said in a release.

But the speed and secrecy of the rollout has rattled outside experts, who warn of hallucinations, automation bias, and data-privacy pitfalls. STAT’s Katie Palmer and Casey Ross lay out five burning questions about the agency’s new AI effort.

artificial intelligence

Insitro slashes staff to extend cash runway

Speaking of AI, Insitro, the AI drug development company launched by Stanford’s Daphne Koller, has cut 22% of its workforce — about 60 people. The company has raised more than $600 million since 2018, and is framing this as a “proactive action” that extends the company’s cash through 2027, STAT’s Jason Mast writes.

The move follows the quiet shelving of Insitro’s oncology ambitions, and comes amid the currently challenging biotech funding climate. Insitro has yet to put a drug into clinical trials, but with the cuts Insitro said it would be able to reach “multiple preclinical and clinical inflection points” for six different programs. It’s hoping to enter clinical trials by 2026.

vaccines

EMA investigates chikungunya vaccine safety

From STAT’s Helen Branswell: The European Medicines Agency’s safety committee has started a review of Valneva’s chikungunya vaccine after a string of concerning reports of serious adverse events in older adults who received the vaccine, marketed as Ixchiq. Globally there have been 17 such events so far, including two deaths. At least six of these events have happened in the United States, data presented last month to the CDC’s vaccines advisory panel, ACIP, suggest. The serious adverse reactions have been seen in individuals aged 62 to 89.

ACIP recommended the vaccine’s label be updated to include a caution about the potential risk its use in older adults. The EMA has gone a step further, recommending against giving it to people 65 and older, as well as people whose immune systems have been weakened by disease or medical treatments, while the investigation is underway.

The deaths occurred in La Réunion, an island in the Indian Ocean that is a department of France, which is experiencing an outbreak of the mosquito-borne disease.

podcast

A firebrand takes oversight of vaccines, gene therapies

What does the appointment of Vinay Prasad as the head of biologic drug evaluation mean for biotechs? Is his fiery public persona suited for government service? We discuss this and other burning questions on a new episode of “The Readout LOUD," STAT’s biotech podcast.

Matthew Herper joins Adam and Allison to examine Prasad’s appointment and the band of outsiders now in charge of U.S. health agencies. He and Adam debate just how disruptive Prasad’s tenure could be.

Listen here.

approvals

FDA approves Verastem's ovarian cancer treatment

The FDA has granted accelerated approval to Verastem’s combination treatment for ovarian cancer. It licensed and has paired two drugs — avutometinib, an MEK inhibitor first developed by Roche subsidiary Chugai Pharmaceutical, with defactinib, an adhesion kinase blocker developed by Pfizer. The approval is for adults with a recurrent KRAS-mutated form of the disease who have already received systemic therapy.

The approval of the treatment, called Avmapki Fakzynja, is based on a study of 57 pre-treated patientes who showed a 44% overall response rate, with responses lasting up to 31 months. The company is also testing this combination in Phase 1/2 trial in patients with front-line metastatic pancreatic cancer.

More around STAT