FDA Issues CRL for Regeneron's Best-in-Class BCMAxCD3 Bispecific Linvoseltamab Amid Manufacturing Concerns

Aug 22, 2024 12:38 CST Updated 12:38

Regeneron

Biopharmaceutical Manufacturer

Recently,FDA Thwarts Regeneron's Plan to Challenge Johnson & Johnson and Pfizer in Blood Cancer Market, Issues CRL to Biotech Giant Over Third-Party Manufacturer Issues

Regeneron Applies for Approval of Its BCMAxCD3 Bispecific Antibody Linvoseltamab Based on Phase 1/2 Data for the Treatment of Relapsed or Refractory Multiple Myeloma. The FDA Accepted the Application for Priority Review and Set a Decision Date for August 22. However, Regeneron Now Reveals That the Decision Is Likely to Be Delayed Beyond the Original PDUFA Date Due to Manufacturing Issues.

Linvoseltamab, a multiple myeloma drug, is one of many promising hematology drugs in Regeneron's pipeline.Regeneron even believes that this drug should be a potential Best-in-class.. Full of anticipation for it.

Of course, this is not the first setback Regeneron has faced with Linvoseltamab. According to news from last December, the response to Regeneron's bispecific Linvoseltamab increased, but so did the adverse events and deaths associated with the multiple myeloma drug. In the early trials, all patients reported at least one adverse event.In the 2022 ASH update, Regeneron reported that 95% of patients experienced some type of adverse event. In the update on Thursday of that year, this figure rose to 100%., 85% of patients experienced grade 3 or more severe events. The company stated that the most common adverse event in the study was cytokine release syndrome (CRS), with the majority of cases being grade 1.In addition, Regeneron said that 14 patients died from "treatment-emergent" adverse events, with 11 of them dying from infections.

Although, later experimental results showed that the total effective rate of Linvoseltamab was 71%, higher than Johnson & Johnson's Tecvayli and Pfizer's Elrexfio., which only reflects the differences between trials rather than the efficacy of the drug. Meanwhile, Linvoseltamab’s complete response rate of 46% is also quite competitive. In addition to efficacy, Regeneron has also identified the rate of cytokine release syndrome and the speed at which adverse events occur as a potential differentiator that could benefit Linvoseltamab.Patients using Linvoseltamab may require shorter hospital stays compared to those taking similar drugs, and Regeneron has been exploring the possibility of reducing the frequency of dosing.

On Tuesday night, Regeneron announced,Represents the FDA's CRL, involving the pre-approval inspection results of a third-party filler/final product manufacturer for another company's candidate product.。

The third-party manufacturer told Regeneron that it believes the FDA's findings have been resolved and is now awaiting re-inspection, which may lead to the case being closed. Regeneron also made similar comments during its earnings call in early August, suggesting that the manufacturer still had at least a few weeks to complete the required fixes. Regeneron stated that the re-inspection is expected to occur "in the coming months." During the earnings call,Regeneron CEO Leonard Schleifer, M.D., referred to the rejections related to production issues and third-party filling equipment as "an industry-wide issue," and added, "I believe the FDA is actually planning to hold some kind of public hearing on this type of matter."

Similar incidents include last year's rejection of Regeneron's Eylea HD application approval due to inspection results at the Catalent facility.The company obtained approval for Eylea HD seven weeks after the disclosure was rejected., and is currently actively cooperating with the FDA together with third-party manufacturers in order to quickly resolve the setback faced by Linvoseltamab.

Meanwhile, the bispecific drug is still under review by the European Medicines Agency., the data it generates suggests that despite strong performance by its competitors' products, it may still carve out a niche in the multiple myeloma market.

References:

Firece

●ADC "FIC Target" Development: Chinese Innovative Pharmaceutical Companies Take the Lead!

●GSK’s B7-H3 ADC Drug, Acquired for $1.7 Billion, Granted FDA Breakthrough Therapy Designation

●First in China! Qilu Pharmaceutical's "Ranibizumab Injection" Biosimilar Approved for Marketing