What's Happening?
The FDA has granted approval for GSK's Blenrep, an anti-BCMA antibody-drug conjugate, as a third-line treatment for multiple myeloma. This approval comes three years after the drug was removed from the market
due to failing a confirmatory trial. Blenrep is now approved for use in combination with Takeda's Velcade and dexamethasone. However, the FDA did not approve a second regimen involving Bristol Myers Squibb's Pomalyst and dexamethasone, likely due to concerns about ocular toxicity. The approval follows a negative vote from the FDA's Oncologic Drugs Advisory Committee in July. The drug's use is restricted to third-line settings in the U.S., unlike other markets such as the EU, UK, and Japan, where it is approved for second-line use.
Why It's Important?
The approval of Blenrep is significant for GSK as it attempts to restore the drug's market presence and achieve peak sales targets of approximately $4 billion. The narrower label in the U.S. market could impact sales and the drug's rollout pace. Blenrep's approval is based on results from the DREAMM-7 trial, which demonstrated improved clinical outcomes in third-line or later myeloma populations. The drug fulfills a major patient need by being the only anti-BCMA agent that can be administered across various healthcare settings, including community centers where most patients receive care. GSK aims to expand Blenrep's use into first-line settings, which is crucial for achieving its sales targets.
What's Next?
GSK is conducting the DREAMM-10 study to explore Blenrep's use in newly diagnosed, transplant-ineligible multiple myeloma patients. This study compares Blenrep plus lenalidomide and dexamethasone against Darzalex plus lenalidomide and dexamethasone. The outcome of this study could potentially expand Blenrep's label to include first-line treatment, which is essential for meeting GSK's sales goals. The company will closely monitor the drug's rollout and its impact in the U.S. market, given the restrictions on its use.
Beyond the Headlines
The FDA's decision reflects ongoing concerns about drug safety, particularly regarding ocular toxicity associated with Blenrep. The approval process highlights the challenges pharmaceutical companies face in balancing efficacy and safety, especially for drugs intended for serious conditions like multiple myeloma. The narrower label may influence GSK's strategic decisions and investment in further clinical trials to expand the drug's indications.
