FDA clears return of GSK’s once-withdrawn multiple myeloma drug

The U.S. Food and Drug Administration (FDA) has granted approval for GSK’s Blenrep, a multiple myeloma treatment that was previously withdrawn from the market. Originally approved in 2020, the drug faced a market exit just two years later due to safety concerns and efficacy issues, marking a significant setback for GSK in the oncology space.

This unexpected re-approval not only highlights the evolving landscape of regulatory assessments but also underscores the potential for second chances in drug development. The FDA’s decision may reflect new data or a reassessment of the drug’s risk-benefit profile, which could pave the way for GSK to regain market confidence and address unmet needs in multiple myeloma treatment.

For pharma B2B professionals, this development serves as a reminder of the dynamic nature of drug approvals and the importance of continuous monitoring of regulatory shifts. Companies involved in regulatory affairs, quality assurance, and clinical development should take note of the implications this may have on their own product pipelines and strategic planning.