FDA has requested that GSK plc (LSE/NYSE:GSK) withdraw the relapsed and refractory multiple myeloma drug Blenrep (belantamab mandolin-blmf) from the U.S. market.
GSK announced in a statement that it has initiated the process.
On November 7, the company announced that the drug did not meet its primary endpoint of progression-free survival (PFS) in the Phase 3 DREAMM-3 study. The humanized IgG1κ monoclonal antibody thus did not comply with FDA’s accelerated approval requirements.
In the study, Blenrep was pitted against Bristol Myers Squibb’s (Nasdaq:GILD), Pomalyst (pomalidomide) and dexamethasone.
GSK shares were up about a percentage point to $33.78.
The FDA approval covered patients with relapsed or refractory multiple myeloma treated with at least four earlier therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulator.
FDA notes that Blenrep is a first-in-class treatment.
GSK will offer patients enrolled in the Blenrep Risk Evaluation and Mitigation Strategy (REMS) program the option to continue receiving the drug as part of a compassionate use program.
The company remains optimistic about Blenrep’s benefit-risk profile in patients with relapsed or refractory multiple myeloma.
GSK’s chief medical officer, Sabine Luik, noted in a statement that the company respects FDA’s ”approach to the accelerated approval regulations and associated process.”
“We will continue the DREAMM clinical trial program and work with the US FDA on a path forward for this important treatment option for patients with multiple myeloma,” Luik added.
In addition to DREAMM-3, GSK has ongoing clinical trials focused on Blenrep, including DREAMM-7 and DREAMM-8. The DREAMM-7 study is testing the combination of belantamab mafodotin, dexamethasone and bortezomib (Velcade) against daratumumab (Darzalex), bortezomib and dexamethasone.
The DREAMM-8 trial is comparing the safety and efficacy of belantamab mafodotin with pomalidomide (Pomalyst) and dexamethasone against pomalidomide, bortezomib and dexamethasone.
FDA and the European Union both approved Blenrep in August 2020.
About a year ago, GSK announced that it would present 11 abstracts at the Society of Hematology (ASH) Annual Meeting and Exposition.