Monday, the FDA issued complete response letters (CRL) to Regeneron Pharmaceuticals Inc’s (NASDAQ:REGN) Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBCL), each after two or more lines of systemic therapy.
The FDA said it needs more data from enrollments in dose-finding and confirmatory portions of trials while confirming no issues with clinical efficacy or safety, trial design, labeling, or manufacturing.
Regeneron has been actively enrolling patients in multiple Phase 3 trials for odronextamab as part of the OLYMPIA program.
Enrollment in the dose-finding portion has begun, but the CRLs indicate that the confirmatory portions of these trials should be underway and that the timelines to completion be agreed upon before resubmission.
Regeneron plans to share updates on enrollment and regulatory timelines later this year.
Regulatory review of odronextamab remains ongoing by the European Medicines Agency (EMA) for R/R DLBCL and R/R FL.
Citing Regeneron, Reuters reported that “it was the first time” a CRL for this reason was issued by the FDA, which has lately been working to raise the bar for cancer drug developers seeking accelerated approval for their candidates.
While odronextamab was poised to be Regeneron’s inaugural blood cancer treatment, its market potential is limited to around $200 million due to stiff competition in the lymphoma space, Reuters reported, citing RBC Capital Markets analyst.
The analyst suggested that the delay in its launch wouldn’t greatly affect Regeneron’s overall performance, as odronextamab was expected to generate only marginal revenue.
Price Action: REGN shares are down 0.62% at $961.23 on the last check Monday.
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