The US Food and Drug Administration (FDA) on Wednesday extended the review period for the Biologics License Application (BLA) for GSK plc’s (NYSE:GSK) Blenrep combinations for relapsed or refractory multiple myeloma patients who have received at least one prior line of therapy.
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The new Prescription Drug User Fee Act (PDUFA) action date is Oct. 23, which allows the FDA to review additional information provided in support of the application.
The BLA is supported by efficacy results shown by Blenrep combinations in the pivotal DREAMM-7 and DREAMM-8 phase 3 trials in relapsed or refractory multiple myeloma.
Also Read: UK Becomes First Country To Authorize Blenrep In Two Combo Regimens
These include statistically significant and clinically meaningful progression-free survival results for Blenrep combinations versus triplet standard of care combinations in both trials and overall survival versus a daratumumab-based triplet in DREAMM-7.
The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.
GSK is confident in the data supporting Blenrep combinations and looks forward to ongoing constructive conversations with the FDA as they continue their review.
Blenrep combinations are currently approved in the UK, Japan, Canada, Switzerland (DREAMM-8 only at this time), and the United Arab Emirates. Applications are currently under review in all major markets globally, including the EU and China (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application).
Last week, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK’s Blenrep combinations.
Ahead of the meeting, the FDA staff released a document highlighting key issues, including high rates of ocular toxicity, such as keratopathy (changes in the corneal epithelium) and changes in visual acuity, as well as poor tolerability with each regimen, resulting in uncertainty regarding the appropriateness of the proposed dosages of belantamab mafodotin.
Despite differences in the belantamab mafodotin dosing regimens evaluated in DREAMM-7 and DREAMM-8, there were high rates of ocular toxicity in both trials.
GSK Price Action: GSK shares were down 0.04% at $38.01 at the time of publication on Thursday, according to Benzinga Pro.
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