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.
It may be a year later than originally planned, but Regeneron Pharmaceuticals Inc. is set to commercialize Lynozyfic (linvoseltamab) in the U.S. following FDA approval for use in adults with relapsed and refractory multiple myeloma. A bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, Lynozyfic was cleared under the accelerated approval pathway, with continued approval contingent upon a confirmatory trial.
Cartesian Therapeutics Inc. followed up December’s phase IIb data with more good news regarding Descartes-08, offering 12-month efficacy and safety results that whetted Wall Street’s appetite for the phase III Aurora effort ahead. Milos Miljkovic, chief medical officer, told BioWorld that minimum symptom expression – among the areas where Descartes-08 shone, providing relief for “months and months after the last dose of treatment” – is especially important to patients.
In a deal that brings $60 million in cash and equity up front, plus up to $575 million in milestone payments, Shanghai-based Epimab Biotherapeutics Inc. and San Diego-based Vignette Bio Inc. entered a licensing agreement for Epimab’s BCMA-targeting T-cell engager, EMB-06, for autoimmune disease.
In a deal that brings $60 million in cash and equity up front, plus up to $575 million in milestone payments, Shanghai-based Epimab Biotherapeutics Inc. and San Diego-based Vignette Bio Inc. entered a licensing agreement for Epimab’s BCMA-targeting T-cell engager, EMB-06, for autoimmune disease.
Mixed opinions from the U.S. FDA’s Oncology Drugs Advisory Committee last month didn’t stop the agency from green-lighting an expanded label for Abecma (idecabtagene vicleucel) to include adults with relapsed or refractory multiple myeloma (r/r MM) after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.
China’s NMPA has approved Carsgen Therapeutics Holdings Ltd.’s NDA for its B-cell maturation antigen (BCMA)-targeted CAR T-cell therapy, zevorcabtagene autoleucel (CT-053, zevor-cel), for treating adults with relapsed or refractory (r/r) multiple myeloma (MM) who have progressed after at least three prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent.
China’s NMPA has approved Carsgen Therapeutics Holdings Ltd.’s NDA for its B-cell maturation antigen (BCMA)-targeted CAR T-cell therapy, zevorcabtagene autoleucel (CT-053, zevor-cel), for treating adults with relapsed or refractory (r/r) multiple myeloma (MM) who have progressed after at least three prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent.
Less than a week after approving Johnson & Johnson’s bispecific antibody, Talvey (talquetamab-tgvs), for relapsed or refractory multiple myeloma (r/r MM) under accelerated review, the U.S. FDA has followed suit with Pfizer Inc.’s equivalent, Elrexfio (elranatamab-bcmm). The accelerated clearance of Elrexfio – a B-cell maturation antigen (BCMA) bispecific antibody that targets BCMA on myeloma cells and the CD3 receptor on T cells – covers it for adult patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
