What's Happening?
GSK has successfully reintroduced its multiple myeloma therapy, Blenrep (belantamab mafodotin), to the U.S. market with a narrower label. The FDA has approved Blenrep as a third-line treatment for multiple myeloma in combination
with Velcade (bortezomib) and dexamethasone. This comes after the drug was previously withdrawn from the market due to failing a confirmatory trial. The FDA did not approve a second regimen involving Pomalyst (pomalidomide) and dexamethasone, likely due to concerns about ocular toxicity. The drug's reintroduction is based on positive results from the DREAMM-7 and DREAMM-8 trials.
Why It's Important?
The return of Blenrep to the U.S. market is significant for GSK as it seeks to regain its position in the multiple myeloma treatment landscape. The narrower label limits its use to third-line settings, which may impact its market potential. However, the approval provides a treatment option for patients who have exhausted other therapies. GSK aims for peak sales of around $4 billion, and the drug's performance in the U.S. market will be closely monitored. The approval also highlights the challenges and complexities of drug development and regulatory approval processes.
What's Next?
GSK is likely to focus on expanding Blenrep's use into earlier lines of treatment, which could enhance its market potential. The company is conducting the DREAMM-10 study to evaluate Blenrep in newly diagnosed, transplant-ineligible multiple myeloma patients. The outcomes of this study will be critical for future regulatory submissions and potential label expansions. GSK will also need to address the safety concerns associated with Blenrep to ensure its long-term success in the market.
