GSK plc GSK announced that the FDA accepted its biologics license application (BLA) seeking approval for the Blenrep (belantamab mafodotin) combination therapy to treat relapsed or refractory multiple myeloma (RRMM) for review.
The BLA seeks the approval of Blenrep in combination with J&J’s Velcade (bortezomib) plus dexamethasone (BorDex) or Bristol Myers’ Pomalyst (pomalidomide) plus dexamethasone (PomDex) for the treatment of patients with multiple myeloma who have received at least one prior line of therapy.
With the FDA accepting the BLA for review, a decision from the regulatory body is expected on July 23, 2025.
Year to date, shares of GSK have lost 7.9% compared with the industry’s 9% decline.
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GSK's BLA Supported by DREAMM-7 and DREAMM-8 Studies
The BLA for the Blenrep combo was based on data from the III DREAMM-7 and DREAMM-8 studies, both of which met their primary endpoints of progression-free survival (PFS).
Data from both studies showed that treatment with the Blenrep combo led to statistically significant and clinically meaningful improvements in PFS versus standard-of-care triplet combinations in RRMM patients.
Data from a subsequent interim analysis of the DREAMM-7 study showed that treatment with the Blenrep combo demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit — a key secondary endpoint of the study.
The safety and tolerability of Blenrep combinations in both studies were generally consistent with the known profiles of the individual agents.
Regulatory applications seeking approval for the combination use of Blenrep in RRMM are also currently under review in the EU and some other countries.
The Earlier Approval and Subsequent Withdrawal of GSK's Blenrep
Blenrep was initially granted accelerated approval in the United States as a monotherapy for RRMM in patients who had received at least four prior therapies in 2020, based on data from the DREAMM-2 study’s overall response rate. The drug was also approved in the EU for the same indication on a conditional basis.
The final approval of the drug was contingent upon a confirmed clinical benefit from a randomized phase III study.
However, in November 2022, Blenrep was withdrawn from the U.S. market after the failure of GSK’s phase III confirmatory study, DREAMM-3, which evaluated Blenrep in patients with relapsed or refractory multiple myeloma. The study failed to meet its primary endpoint of PFS, thereby failing to meet the FDA’s accelerated approval regulations.
Consequently, Blenrep monotherapy as a treatment for RRMM was also withdrawn from the EU market as well.
The FDA acceptance of the latest BLA filing for Blenrep combinations to treat RRMM gives GSK hopes of bringing the drug back to the market for patients with this dreadful disease.
GSK's Zacks Rank & Key Picks
GSK currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR, Spero Therapeutics, Inc. SPRO and Castle Biosciences, Inc. CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 52.1%.
IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.
In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.13. Loss per share estimates for 2025 have narrowed from $1.54 to 54 cents during the same time. Year to date, shares of SPRO have declined 21.7%.
SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 36.8%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
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