FDA Rejects Multiple New Drug Applications from Roche, GSK, and Replimune Within a Week

　　【Pharmaceutical Network Industry DynamicsRecently, the U.S. FDA has successively rejected several drug applications. These include Replimune's accelerated approval application for the melanoma candidate drug RP1; Genentech’s (under Roche) CD20/CD3 bispecific antibody Columvi, and GlaxoSmithKline (GSK)’s BCMA-targeted antibody-drug conjugate (ADC) Blenrep marketing applications.
 

Specifically, on July 22, the U.S. FDA issued a Complete Response Letter (CRL) to biotech company Replimune, formally rejecting the accelerated approval application for its melanoma candidate drug RP1.
 

According to reports, RP1 is a virus-based immunotherapy that directly kills cancer cells by modifying the virus while activating the human immune system to continuously attack tumors. Replimune submitted an accelerated approval application based on phase 1/2 Ignite trial data. However, the FDA clearly stated in the CRL that the trial "was not a well-controlled clinical study providing sufficient evidence of efficacy." Additionally, the FDA raised questions about Replimune's phase 3 confirmatory trial.
 

On July 18, Roche and its subsidiary Genentech announced that the U.S. FDA had issued a Complete Response Letter (CRL), refusing to approve the supplemental Biologics License Application (sBLA) for Columvi in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of patients with second-line diffuse large B-cell lymphoma (DLBCL).
 

CRL Shows That FDA Considers STARGLO Study Failed to Provide Sufficient Evidence to Demonstrate the Benefits of This Treatment Regimen for the U.S. Patient Population. Reportedly, 59% of the enrolled population in this study came from Asia or Australia, 32% from Europe, and only 9% from North America.
 

On July 17, GSK announced that the FDA rejected the approval of its BCMA ADC drug Blenrep for second-line combination therapy in relapsed or refractory multiple myeloma, citing that its risks outweighed the benefits.
 

The two Phase 3 clinical trials (DREAMM-7 and DREAMM-8) for this new drug both met the primary endpoint of progression-free survival (PFS). Additionally, DREAMM-7 achieved the key secondary endpoint of overall survival (OS). However, the main reason for its rejection was that Blenrep failed to reach the key secondary endpoint of OS in the pivotal DREAMM-8 trial. Furthermore, the results of the two Phase 3 clinical trials for Blenrep were contradictory. While DREAMM-7 achieved the key secondary endpoint of OS, DREAMM-8 did not. This inconsistency raised doubts among experts about its actual efficacy.
 

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Overall, the FDA's consecutive rejections indicate that "Successful Phase III ≠ Approval." Industry insiders believe that, based on recent reasons for pharmaceutical companies being rejected by the FDA—most of which are related to safety and efficacy issues, manufacturing defects, and bioequivalence problems—in the future, pharmaceutical companies should adopt a more precise and meticulous approach to meet standards in three aspects: efficacy, safety, and data representation, in order to successfully pass regulatory hurdles.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice to any person.