FDA accepts GSK's BLA for Blenrep combos in Multiple Myeloma for review

From Nasdaq: 2024-11-26 10:23:00

GSK’s BLA for Blenrep combo therapy to treat RRMM has been accepted by the FDA for review. The decision is expected on July 23, 2025. The BLA includes combinations with Velcade plus dexamethasone or Pomalyst plus dexamethasone for patients who have received prior therapy. Shares of GSK have declined 7.9% this year.

The BLA is supported by positive data from the DREAMM-7 and DREAMM-8 studies, showing significant improvements in progression-free survival for RRMM patients. An interim analysis of DREAMM-7 also demonstrated a statistically significant overall survival benefit. Safety profiles were consistent with known agent profiles, with regulatory applications under review in the EU.

Blenrep was initially granted accelerated approval in the U.S. as a monotherapy for RRMM in 2020 but was later withdrawn due to the failure of the phase III DREAMM-3 study to meet its primary endpoint. The drug was also withdrawn from the EU market. The latest BLA filing for Blenrep combinations gives hope for reintroducing the drug.

GSK currently holds a Zacks Rank #4 (Sell). Better-ranked biotech stocks include IMCR, SPRO, and CSTL, each with a Zacks Rank #1 (Strong Buy). IMCR’s earnings estimates for 2024 and 2025 have narrowed, with a decline in share price year to date. SPRO and CSTL also show narrowed loss per share estimates and share price performance.

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