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>>> FDA rejects Regeneron lymphoma drug, setting back company’s oncology push


Industry Dive

by Jonathan Gardner

March 25, 2024


https://finance.yahoo.com/news/fda-rejects-regeneron-lymphoma-drug-115500198.html


The Food and Drug Administration declined to approve an experimental lymphoma drug from Regeneron Pharmaceuticals, asking the company to first make more progress with a trial meant to confirm benefits observed in earlier testing, the company said Monday.

Regeneron said the FDA “did not identify any approvability issues” related to the safety, effectiveness or manufacturing of the drug, which is known as odronextamab. However, the agency wants to see study participants enrolled in the “dose finding” as well as “confirmatory” parts of an ongoing Phase 3 trial before it will issue a verdict, the company said.

Should it ultimately win approval, odronextamab would compete for market share with similar, “bispecific” drugs from AbbVie and Roche. Those drugs were greenlit in 2023 and posted sales of $17 million and $65 million, respectively.

Dive Insight:

Since cracking down on “dangling” accelerated approvals for cancer drugs – conditional clearances that weren’t confirmed through further testing – the FDA has been more hesitant to grant new ones. In Regeneron’s case, the drugmaker has been seeking a speedy approval in two types of lymphoma based on studies that measured remission rates but didn’t compare odronextamab’s performance to a placebo.

Accelerated approvals are conditional and granted on smaller trials that are “likely” to predict a benefit for drug recipients. But companies seeking them must back them up with bigger studies that prove those benefits by testing their therapies against a placebo or existing treatment.

Regeneron has already begun such a trial. However, the agency doesn’t believe Regeneron has made enough progress with enrollment yet, prompting a rejection. The FDA must also sign off on the timelines for the study’s completion before Regeneron resubmits its application. Regeneron will share updates later this year, it said in a statement.

Odronextamab is a type of dual-pronged antibody drug that’s become increasingly popular in recent years. It binds to the same targets on immune and malignant cells as AbbVie’s Epkinly and Roche’s Columvi, both of which won accelerated approvals in B cell lymphomas.

In a research note Monday, Sean McCutcheon, an analyst with Raymond James, wrote that he expects an agreement between Regeneron and the FDA once the “confirmatory” portions of the study begin. Still, the setback represents a missed opportunity for Regeneron, which has struggled to compete with more established players in oncology.

“We continue to see odronextamab as a modest opportunity given competitive headwinds, with the delay as a further hurdle to garnering market share,” he wrote. “The [rejection] also further adds to investor pessimism on the company’s execution within oncology.”

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