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FDA Advisory Panel Votes Against Approval of GSK's Blenrep Combo
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Key Takeaways
GSK's Blenrep combo failed to gain ODAC backing due to an unfavorable benefit/risk profile.
The ODAC vote comes ahead of the FDA's July 23 decision on GSK's biologics license application.
The Blenrep combo was approved in the UK and Japan but faces regulatory hurdles in the United States.
GSK plc (GSK - Free Report) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk profile of the Blenrep (belantamab mafodotin-blmf) combination therapy at the proposed dosing regimen.
It can be inferred that the ODAC thinks the risk of treatment with the Blenrep combo currently appears to outweigh its benefit profile at the proposed dose for treating adults with relapsed or refractory multiple myeloma.
Shares of GSK were down 4.7% yesterday following the announcement of the news.
The ODAC’s opinion comes just a week ahead of the FDA’s final decision on its review of GSK’s biologics license application (BLA), which sought 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.
Given that the FDA usually considers the ODAC opinion, it can be inferred that the regulatory body might reject the approval for the Blenrep combo in the United States.
GSK's Price Performance
Year to date, shares of GSK have risen 7.8% against the industry’s decrease of 0.6%.
Image Source: Zacks Investment Research
More on GSK's Blenrep Combo
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).
Regulatory applications seeking approval for the combination use of Blenrep in relapsed or refractory multiple myeloma are currently under review in the EU and some other countries.
We remind investors that in November 2022, Blenrep was withdrawn from the U.S. market after the failure of GSK’s phase III confirmatory study, DREAMM-3, which evaluated Blenrep in patients with relapsed or refractory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 relapsed or refractory multiple myeloma was also withdrawn from the EU market.
Blenrep combinations were approved in the United Kingdom and Japan in April/May 2025.
However, at present, it is not likely that the Blenrep combo would be approved in the United States, jolting GKS’s hopes of reviving the drug.
In the past 60 days, estimates for Arvinas’ 2025 loss per share have improved from $1.60 to $1.51. Loss per share estimates for 2026 have narrowed from $3.28 to $2.98 during the same period. ARVN stock has plunged 59.5% year to date.
Arvinas’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 82.09%.
In the past 60 days, estimates for Keros Therapeutics’ 2025 loss per share have improved from 79 cents to 29 cents. Loss per share estimates for 2026 have narrowed from $4.52 to $4.29 during the same period. KROS stock has decreased 9.3% year to date.
Keros Therapeutics’ earnings beat estimates in one of the trailing four quarters, while missing the same on the remaining three occasions, delivering an average surprise of 9,065.97%.
In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have improved from $4.00 to $3.96. Loss per share estimates for 2026 have narrowed from $4.34 to $4.27 during the same period. Year to date, shares of AKRO have surged 95.3%.
Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 48.90%.
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FDA Advisory Panel Votes Against Approval of GSK's Blenrep Combo
Key Takeaways
GSK plc (GSK - Free Report) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk profile of the Blenrep (belantamab mafodotin-blmf) combination therapy at the proposed dosing regimen.
It can be inferred that the ODAC thinks the risk of treatment with the Blenrep combo currently appears to outweigh its benefit profile at the proposed dose for treating adults with relapsed or refractory multiple myeloma.
Shares of GSK were down 4.7% yesterday following the announcement of the news.
The ODAC’s opinion comes just a week ahead of the FDA’s final decision on its review of GSK’s biologics license application (BLA), which sought 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.
Given that the FDA usually considers the ODAC opinion, it can be inferred that the regulatory body might reject the approval for the Blenrep combo in the United States.
GSK's Price Performance
Year to date, shares of GSK have risen 7.8% against the industry’s decrease of 0.6%.
Image Source: Zacks Investment Research
More on GSK's Blenrep Combo
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).
Regulatory applications seeking approval for the combination use of Blenrep in relapsed or refractory multiple myeloma are currently under review in the EU and some other countries.
We remind investors that 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 relapsed or refractory multiple myeloma was also withdrawn from the EU market.
Blenrep combinations were approved in the United Kingdom and Japan in April/May 2025.
However, at present, it is not likely that the Blenrep combo would be approved in the United States, jolting GKS’s hopes of reviving the drug.
GSK's Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the biotech sector are Arvinas (ARVN - Free Report) , Keros Therapeutics (KROS - Free Report) and Akero Therapeutics (AKRO - Free Report) , 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 Arvinas’ 2025 loss per share have improved from $1.60 to $1.51. Loss per share estimates for 2026 have narrowed from $3.28 to $2.98 during the same period. ARVN stock has plunged 59.5% year to date.
Arvinas’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 82.09%.
In the past 60 days, estimates for Keros Therapeutics’ 2025 loss per share have improved from 79 cents to 29 cents. Loss per share estimates for 2026 have narrowed from $4.52 to $4.29 during the same period. KROS stock has decreased 9.3% year to date.
Keros Therapeutics’ earnings beat estimates in one of the trailing four quarters, while missing the same on the remaining three occasions, delivering an average surprise of 9,065.97%.
In the past 60 days, estimates for Akero Therapeutics’ 2025 loss per share have improved from $4.00 to $3.96. Loss per share estimates for 2026 have narrowed from $4.34 to $4.27 during the same period. Year to date, shares of AKRO have surged 95.3%.
Akero Therapeutics’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 48.90%.