The rough ride presaged by briefing documents came to pass for GSK plc with the drug first approved by the U.S. FDA as Blenrep (belantamab mafodotin, bel-maf), as the agency’s Oncologic Drugs Advisory Committee (ODAC) appraised the possibility that the antibody-drug conjugate could return to market for relapsed/refractory multiple myeloma (r/r MM).
As the July 23 PDUFA date nears for GSK plc’s Blenrep (belantamab mafodotin), the U.S. FDA’s Oncologic Drugs Advisory Committee will decide July 17 on whether available data justify the return to market of the antibody-drug conjugate as a therapy for relapsed/refractory multiple myeloma, and briefing documents made public ahead of the meeting laid out the issues.
GSK plc’s Blenrep (belantamab mafodotin) is heading back to the market three years after being withdrawn, with the EMA’s Committee for Medicinal Products for Human Use recommending approval of the antibody-drug conjugate in combination therapy for the treatment of adults with relapsed or refractory multiple myeloma.
GSK plc is looking at a comeback for Blenrep (belantamab mafodotin) as an interim efficacy analysis brought the company good news. Almost exactly a year ago, phase III confirmatory study data for the already-approved multiple myeloma drug fell short of the U.S. FDA’s accelerated approval requirements, so the agency asked GSK to take the drug off the market for the indication.
As GSK plc pulls Blenrep (belantamab mafodotin) from the U.S. market, the biotech giant will watch a lot of revenue go with it. Only two weeks ago a phase III confirmatory study data for the already-approved multiple myeloma drug fell short of meeting requirements for the U.S. FDA’s accelerated approval regulations, so the agency asked GSK to take the drug off the market.
There are doubts about the future of GSK plc’s multiple myeloma drug Blenrep (belantamab mafodotin) after it failed to meet its goal of improving progression-free survival compared with standard chemotherapy in a confirmatory trial, placing its conditional approvals in the U.S. and Europe at risk.
Glaxosmithkline plc CEO Emma Walmsley has set out further details of the company’s forthcoming split, saying that the firm’s late-stage pipeline could help deliver sales of more than £33 billion by 2031.
While acknowledging the net health benefit over standard of care in heavily pretreated multiple myeloma patients, CAR T-cell therapies Abecma (idecabtagene vicleucel) and ciltacabtagene autoleucel (cilta-cel) represent low long-term value at their current pricing levels, according to the Institute for Clinical and Economic Review (ICER) in a final evidence report released May 11.
Citing the limited data for CAR T therapies in treating multiple myeloma, the Institute for Clinical and Economic Review said their cost-effectiveness for some patients will depend on whether a second dose is needed.
About two weeks after European regulators gave their go-ahead for Blenrep (belantamab mafodotin-blmf), the B cell maturation antigen (BCMA)-targeting therapy from Glaxosmithkline plc (GSK) for relapsed/refractory multiple myeloma (MM), the FDA did likewise.
