Pharmaceutical company GSK's planned return for Blenrep faces a hold-up, following the Food and Drug Administration's postponement of a decision on the treatment's approval.
In a recent development, the Food and Drug Administration (FDA) has extended the review period for GlaxoSmithKline's (GSK) antibody-drug conjugate Blenrep. The delay, which pushes the target action date to October 23, 2025, is due to the FDA's need for more time to review additional information submitted by GSK in support of the application.
The extension comes amidst concerns about the ocular side effects associated with Blenrep, which have been a topic of discussion during FDA reviews. In July 2025, an FDA advisory committee expressed concerns about these side effects and overall dosing and tolerability.
Another point of contention is the risk-benefit profile of Blenrep in combination with other therapies. The FDA's Oncologic Drugs Advisory Committee (ODAC) recently voted against the use of Blenrep with Velcade (bortezomib) and dexamethasone, as well as with Pomalyst (pomalidomide) and dexamethasone.
Blenrep initially received approval in August 2020 under the FDA's accelerated pathway for the second-line treatment of relapsed or refractory multiple myeloma. However, the drug faced significant setbacks after failing to meet expectations in a confirmatory Phase III study in November 2022, leading to its withdrawal from the market at that time.
Despite these challenges, GSK has shown promising results from late-stage trials, such as the DREAMM-7 study, which demonstrated a significant reduction in the risk of death or disease progression when Blenrep was used in combination with certain therapies.
It's worth noting that the demographic composition of the studies had limited enrollment in the U.S., and limited enrollment of Black or African American patients and those 75 years of age and older.
The FDA is not required to follow the recommendations of its advisory panels, though it often does. The current status of GSK's aspirations for a market comeback for Blenrep remains uncertain, with the benefit-risk profile of the drug for the proposed indications still unclear according to the FDA's internal reviewers.
[1] GSK's Blenrep Faces Delay as FDA Extends Review Period
[2] FDA Panel Questions Blenrep's Safety and Efficacy
[3] GSK Submits Additional Data for Blenrep Review
[4] EU Approves GSK's Blenrep for Multiple Myeloma Treatment
[5] UK Approves GSK's Blenrep for Multiple Myeloma Treatment
[1] The delay in the FDA's action date for GSK's Blenrep, originally scheduled for October 2025, is due to the FDA's need for more time to review additional information submitted by GSK regarding medical-conditions associated with the drug.
[2] The FDA's Oncologic Drugs Advisory Committee (ODAC) previously voted against the use of Blenrep with certain therapies due to concerns about its risk-benefit profile and ocular side effects, which have been a topic of discussion during FDA reviews.
[3] In an effort to address the FDA's concerns, GSK has submitted additional data to support the application for Blenrep, aiming to clear the path for a potentially successful market comeback for the drug. The finance side of this endeavor would likely depend on the drug's eventual approval and its success in the health-and-wellness market.
