STAT+: FDA to reconsider treatment for rare cancer after its surprise rejection

STAT PlusBreaking News FDA to reconsider treatment for rare cancer after its surprise rejection Atara and Pierre Fabre said they reached an agreement to address agency’s concerns over Ebvallo Manage alerts for this article Email this article Share this article By Adam FeuersteinMay 7, 2026 Adam Feuerstein, a senior writer and biotech columnist, is the author of Adam’s Biotech Scorecard, a subscriber-only newsletter about the crossroads of drug development, business, Wall Street, and biotechnology. Adam Feuerstein[email protected]Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54. Two companies developing a therapy for a rare blood cancer have reached an agreement with the Food and Drug Administration that walked back the agency’s main reason for rejecting the drug in January. Pierre Fabre Pharmaceuticals and Atara Biotherapeutics, makers of the drug called Ebvallo, said Thursday that a meeting held in late April with FDA officials ended with the agency agreeing that their already completed, single-arm clinical trial was sufficient to support a review and potential approval. Advertisement When the FDA rejected Ebvallo, the agency said the same study was flawed and the data produced from it was “insufficient” to support the drug’s approval. The drug’s review was conducted by the FDA’s Center for Biologics Evaluation and Research, led at the time by Vinay Prasad. He departed the agency at the end of April. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%! Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In biotechnology, Cancer, drug development, FDA, Pharmaceuticals, STAT+ Submit a correction requestReprints Adam Feuerstein Senior Writer, Biotech Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54. STAT+ Newsletter Senior writer Adam Feuerstein's unfiltered, uncompromising analysis on the biotech world Recommended Biotech May 7, 2026 STAT Plus: Next-gen Duchenne drug from Entrada disappoints Adam's Biotech Scorecard May 7, 2026 STAT Plus: Color me skeptical: Drinking gold is not an ALS cure Advertisement Biotech May 7, 2026 STAT Plus: Angelini Pharma buys Catalyst Pharmaceuticals and its rare disease drugs for $4.1B The Readout May 6, 2026 STAT Plus: Novo Nordisk’s less-bad news on its Wegovy pill boosts earnings and share price Biotech May 6, 2026 STAT Plus: Even at a meeting in Rome, FDA shifts are top of mind for gene therapy field Subscriber Picks