GSK’s Comeback for Blenrep on Pause as FDA Delays Resolution

The FDA has pushed again its goal determination date for GSK’s antibody-drug conjugate Blenrep, being proposed for the second-line therapy of relapsed or refractory a number of myeloma.

Based on a Wednesday information launch from the pharma, the FDA wants extra time to “assessment extra info offered in help of the applying.” The brand new goal motion date is Oct. 23, 2025; beforehand, a call had been due July 23.

It’s unclear if this delay signifies some hesitation on the a part of the FDA to grant an approval, but it surely does act as one other speedbump to GSK’s aspirations of a market comeback for Blenrep. The antibody-drug conjugate was initially granted approval in August 2020 underneath the regulator’s accelerated pathway. However in November 2022, Blenrep failed the confirmatory Section III DREAMM-3 research, and GSK pulled it from the market quickly after.

Final yr, the pharma launched two late-stage readouts for Blenrep, constructing a case for the drug’s scientific comeback as a second-line therapy choice. In February 2024, for example, a readout from the Section III DREAMM-7 demonstrated that Blenrep, when mixed with bortezomib and dexamethasone, can considerably scale back the chance of dying or illness development by 59% versus a Darzalex-based combo.

In June, GSK additionally introduced information from DREAMM-8, touting Blenrep’s superiority over Takeda’s Velcade, likewise in sufferers who had undergone at the very least one prior line of remedy. These findings, the pharma mentioned on the time, underlined Blenrep’s “multi-blockbuster” potential as a second-line therapy choice.

The FDA doesn’t appear as satisfied, nonetheless. In a briefing doc printed earlier this month, inside company reviewers flagged “the excessive charges of ocular toxicity and dose modifications” in DREAMM-7 and DREAMM-8, which they are saying recommend that GSK had not optimized its dosing routine for the ADC. The security indicators, the reviewers famous, “necessitate a cautious analysis of the dangers related to [Blenrep]. The benefit-risk profile of [Blenrep] for the proposed indications . . . stays unclear.”

The briefing doc additionally took concern with the demographic composition of the research, which had “restricted enrollment within the U.S., and restricted enrollment of Black or African American sufferers and people 75 years of age and older.”

An exterior panel of specialists echoed these issues on the FDA’s Oncologic Medicine Advisory Committee assembly final week, voting 7–1 towards using Blenrep plus pomalidomide and dexamethasone. The committee was break up 5–3 towards Blenrep with bortezomib and dexamethasone. The FDA shouldn’t be required to observe the suggestions of its advisory panels, although it typically does.