©Reuters. FILE PHOTO: The Regeneron Pharmaceuticals company logo is seen on a building at the company’s Westchester campus in Tarrytown, New York, U.S., September 17, 2020. REUTERS/Brendan McDermid
(Reuters) – Regeneron Pharmaceuticals said on Monday the U.S. FDA has rejected approval for its blood cancer therapy for two forms of lymphoma, raising concerns about the progress of ongoing confirmatory trials.
In its so-called complete response letter (CRL), the U.S. Food and Drug Administration said it needed more data from enrollments in the dose-finding and confirmation parts of the trials, delaying its decision on the drug.
The company was testing its experimental drug, odronextamab, in several late-stage studies in patients with follicular lymphoma and diffuse large B-cell lymphoma, the two most common subtypes of non-Hodgkin’s lymphoma.
“To the best of our knowledge, this is the first time the FDA has issued a CRL for this reason,” a spokesperson for Regeneron (NASDAQ:) said of the FDA decision, which did not identify any issues with clinical efficacy or drug safety, design, labeling or testing.
The company’s shares fell nearly 2% to $948.90 in premarket trading. The company was looking to expand its oncology portfolio with odronextamab, in addition to its only approved cancer drug, Libtayo.
“While we recognize the FDA’s general concerns about sponsors who fail to complete their post-marketing confirmatory studies, relevant laws and regulatory guidance do not establish rigid criteria for evaluating whether progress in a confirmatory study is adequate to allow for accelerated approval,” the Regeneron spokesperson said.