2 Blenrep combos for hard-to-treat myeloma approved for adults in EU
But FDA decision on GSK combination treatments pushed to October
Two combination therapies using Blenrep (belantamab mafodotin) — designed to treat adults with relapsed or refractory multiple myeloma — have been approved in the European Union for people with this blood cancer, developer GSK announced.
In the U.S., however, a decision on the combination treatments has been delayed until October, with the U.S. Food and Drug Administration (FDA) extending its review, according to a separate press release from the company.
In the EU, the European Commission approved the combo treatments for adults with hard-to-treat myeloma who have already received at least one prior therapy.
Hesham Abdullah, senior vice president, global head oncology, R&D, at GSK, said the European approval “is a redefining moment for patients with relapsed or refractory multiple myeloma in the EU.”
Blenrep contains an antibody that’s attached to a toxic molecule called auristatin F. The antibody is designed to target BCMA, a protein that’s expressed by myeloma cells. It aims to deliver the toxic molecule to these cancer cells, killing them.
Blenrep previously sold as standalone therapy, but pulled from market
Blenrep was previously granted conditional approval as a standalone treatment for myeloma in both the U.S. and the EU. However, a Phase 3 clinical trial, called DREAMM-3 (NCT04162210), failed to show that Blenrep alone outperformed standard of care therapies, and the medication was ultimately pulled from markets in both the U.S. and the EU.
GSK is now developing Blenrep for use in combination with other therapies. The company recently submitted applications asking various regulatory agencies worldwide to approve Blenrep in combination with Velcade (bortezomib) plus dexamethasone — a combo dubbed BorDex — or Pomalyst (pomalidomide) plus dexamethasone, called PomDex, in people with myeloma who’ve received at least one prior line of treatment.
Blenrep has the potential to extend remission and survival, with superior efficacy versus standards of care.
Those applications are based on data from two Phase 3 clinical trials: DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623). Data from these trials indicated that the risk of disease progression or death was significantly lower with the Blenrep combos relative to standard of care treatments. Further, the safety profile of the treatment combos was shown to be consistent with the known safety profiles of each of the individual therapies used.
According to Abdullah, “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.”
María-Victoria Mateos, MD, PhD, principal investigator on the DREAMM-7 study at the University of Salamanca in Spain, said that the data from the trials, together with the fact that these combos can be administered without the need for hospitalization, “positions Blenrep combinations as a fundamentally differentiated treatment approach for multiple myeloma patients starting from first relapse.”
Based on the results of DREAMM-7 and DREAMM-8, a committee of the European Medicines Agency recommended approval of the Blenrep combos last month. These combination treatments have also been approved by regulators in the U.K., Japan, and, earlier this month, in Canada.
FDA still reviewing data submitted by developer GSK
In the U.S., the FDA has extended its review period, with a decision now expected on Oct. 23.
GSK last week announced that the FDA’s oncologic drugs advisory committee — a panel of experts on cancer treatment — voted against the benefit/risk profile of these Blenrep combos. The company did not provide details about the committee’s concerns. But GSK said it remained “confident” in the treatment’s benefit/risk profile and would work closely with the FDA going forward.
The extended review “provides the FDA with time to review additional information provided in support of the application,” according to GSK.
“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 stated.
For patients in the EU, more information is expected to be available soon from the European Medicines Agency.
Mateos said the approval gives new options to myeloma patients in Europe.
“With the approval of Blenrep combinations in the EU, we now have additional tools in our efforts to keep patients in remission longer, maintain quality of life and extend survival,” Mateos said.
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