Regeneron wins European approval for odronextamab after FDA rejection

Regeneron has achieved a significant milestone with the European approval of its T-cell engager, odronextamab, for treating specific blood cancers. This approval comes five months after the FDA denied the treatment under its accelerated approval pathway, primarily due to the incomplete status of its confirmatory trial.

The European Commission has approved odronextamab, branded as Ordspono, for the treatment of relapsed or refractory follicular lymphoma (FL) and relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This marks Regeneron's first approved bispecific antibody, targeting patients who have undergone at least two lines of systemic therapy.

In addition to Regeneron’s achievement, the European Commission has also granted approval to SIFI’s Akantior (polyhexanide) for acanthamoeba keratitis, a rare corneal infection that can lead to blindness, especially in those who wear soft contact lenses. This makes it the first therapy approved for this condition. The FDA has given polyhexanide orphan drug designation for both acanthamoeba keratitis and fungal keratitis.

Regeneron's approval is supported by data from phase 1 and phase 2 trials. The ELM-2 study showed remarkable results for patients with FL, achieving an 80% overall response rate (ORR) with a 73% complete response (CR) rate. The median duration of response (DoR) for complete responders was 25 months. For patients with DLBCL who had not received CAR-T therapy, the study reported a 52% ORR, with 31% achieving CR and an 18-month median DoR.

Despite these promising results, the FDA issued two complete response letters in March, rejecting Regeneron's application for accelerated approval due to the immaturity of the confirmatory trials for odronextamab. The FDA and Regeneron must agree on the timelines for these trials before resubmission. This rejection highlights the FDA’s ongoing challenges in adjudicating accelerated approvals. Recent scrutiny has been due to the failures of some FDA-sanctioned drugs, with a study indicating that 80% of drugs approved under this pathway failed to show survival benefits after five years.

In April, Dr. Richard Pazdur, chief of the FDA's Oncology Center of Excellence, discussed the issue, emphasizing the need for flexibility when no other therapeutic alternatives exist. However, he also stressed the importance of a level playing field when similar drugs are in the market and sponsors have nearly completed confirmatory studies at the time of accelerated approval.

Odronextamab faces competition from other new treatments in its drug class that have already received FDA approval. AbbVie and Genmab’s bispecific antibody, Epkinly, has been approved for both FL and DLBCL over the past 15 months. Roche has also launched T-cell engagers: Columvi for DLBCL and Lunsumino for FL, approved in June and December 2022, respectively. All these therapies have been endorsed for third-line use, and ongoing clinical trials aim to combine these T-cell engagers with other medications to move them into earlier lines of treatment.

Dr. George Yancopoulos, Regeneron’s chief scientific officer, expressed optimism about the approval, stating, "Ordspono marks the first approval from our bispecific antibody platform, which we hope will increasingly contribute to our growing portfolio of practice-changing medicines for oncology and other diseases." This approval represents a significant step for Regeneron in expanding its innovative treatment options for blood cancer patients.

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