GSK adds EU to Blenrep checklist as FDA sets new PDUFA date

GSK has added the European Medicines Agency to the list of regulatory bodies that have approved Blenrep (belantamab mafodotin) for multiple myeloma, following the UK, Japan, Switzerland, Canada, and the United Arab Emirates. As to whether the US will be added to the list, the company now has a new date by which they'll find out.
In the EU, the drug is approved for use as a second-line treatment in combination with either Takeda's Velcade (bortezomib) and dexamethasone, or with Bristol Myers Squibb's Pomalyst (pomalidomide) and dexamethasone, with the latter requiring that the patient have already tried Celgene's Revlimid (lenalidomide).
Europe is a major market for multiple myeloma, with 50,000 cases diagnosed each year accounting for a quarter of global incidence, according to the World Health Organisation.
“Today’s approval of Blenrep combinations is a redefining moment for patients with relapsed or refractory multiple myeloma in the EU," Hesham Abdullah, SVP and global head of oncology R&D at GSK, said in a statement. "Blenrep has the potential to extend remission and survival, with superior efficacy versus standards of care in our DREAMM clinical trial programme and the option to administer in both academic and community-based settings.”
Originally granted accelerated approval in the US, Blenrep had been all but written off after some poor confirmatory data. But at ASCO 2024, strong results on the DREAMM-7 and DREAMM-8 studies began a compelling comeback story for the anti-BCMA antibody-drug conjugate.
As the regulatory approvals began to flow in, starting with the UK in April, the drug seemed to be back on track, but last week the FDA threw the company another curve ball as the Oncologic Drugs Advisory Committee (ODAC) voted against both treatment regimens that have secured approval elsewhere.
However, yesterday GSK announced that the FDA has extended the review period for Blenrep to give the agency time to review additional materials submitted by the company, suggesting the company may have a strategy for securing approval in the US after all. Its new PDUFA data is October 23rd.
"GSK is confident in the data supporting Blenrep combinations and looks forward to ongoing constructive conversations with the FDA as they continue their review," the company said in a statement.