The new target action date for Blenrep, which GSK is proposing for the second-line treatment of relapsed or refractory multiple myeloma, is Oct. 23.
The FDA has pushed back its target decision date for GSK’s antibody-drug conjugate Blenrep, being proposed for the second-line treatment of relapsed or refractory multiple myeloma.
According to a Wednesday news release from the pharma, the FDA needs more time to “review additional information provided in support of the application.” The new target action date is Oct. 23, 2025; previously, a decision had been due July 23.
It is unclear if this delay indicates some hesitation on the part of the FDA to grant an approval, but it does act as another speedbump to GSK’s aspirations of a market comeback for Blenrep. The antibody-drug conjugate was initially granted approval in August 2020 under the regulator’s accelerated pathway. But in November 2022, Blenrep failed the confirmatory Phase III DREAMM-3 study, and GSK pulled it from the market soon after.
Last year, the pharma released two late-stage readouts for Blenrep, building a case for the drug’s clinical comeback as a second-line treatment option. In February 2024, for instance, a readout from the Phase III DREAMM-7 demonstrated that Blenrep, when combined with bortezomib and dexamethasone, can significantly reduce the risk of death or disease progression by 59% versus a Darzalex-based combo.
In June, GSK also presented data from DREAMM-8, touting Blenrep’s superiority over Takeda’s Velcade, likewise in patients who had undergone at least one prior line of therapy. These findings, the pharma said at the time, underlined Blenrep’s “multi-blockbuster” potential as a second-line treatment option.
The FDA doesn’t seem as convinced, however. In a briefing document published earlier this month, internal agency reviewers flagged “the high rates of ocular toxicity and dose modifications” in DREAMM-7 and DREAMM-8, which they say suggest that GSK had not optimized its dosing regimen for the ADC. The safety signals, the reviewers noted, “necessitate a careful evaluation of the risks associated with [Blenrep]. The benefit-risk profile of [Blenrep] for the proposed indications . . . remains unclear.”
The briefing document also took issue with the demographic composition of the studies, which had “limited enrollment in the U.S., and limited enrollment of Black or African American patients and those 75 years of age and older.”
An external panel of experts echoed these concerns at the FDA’s Oncologic Drugs Advisory Committee meeting last week, voting 7–1 against the use of Blenrep plus pomalidomide and dexamethasone. The committee was split 5–3 against Blenrep with bortezomib and dexamethasone. The FDA is not required to follow the recommendations of its advisory panels, though it often does.
