Ichnos Sciences Inc.’s first-in-class T-cell engaging trispecific antibody, ISB-2001, has been granted orphan drug designation by the FDA for the treatment of multiple myeloma.
The U.S. FDA granted Nanjing Iaso Biotherapeutics Co. Ltd. both regenerative medicine advanced therapy and fast track designations for its new drug, BCMA CAR T-cell therapy CT-103A (equecabtagene autoleucel), allowing it to speed up development and commercialization in the U.S. for the treatment of relapsed/refractory multiple myeloma.
Researchers from Institut d'Investigacions Biomèdiques August Pi i Sunyer and affiliated organizations have reported the development of novel dual CD19/BCMA CAR T cells, referred to as ARI-0003, developed through co-transduction of two lentiviral vectors encoding CARs targeting CD19 (ARI-0001) and BCMA (ARI-0002h).
CAR T specialist Carsgen Therapeutics Holdings Ltd. out-licensed commercial rights for its B-cell maturation antigen (BCMA) CAR T therapy, CT-053, in mainland China to Huadong Medicine Co Ltd. in a deal worth up to $152 million.
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.
The U.S. FDA cleared teclistamab from Janssen Pharmaceutical Cos. as the first bispecific antibody for treating patients with relapsed or refractory multiple myeloma (MM), joining other BCMA-targeted drugs, including an antibody-drug conjugate and CAR T therapies.
Janssen Pharmaceutical Cos, Inc.’s CAR T-cell therapy, Carvykti (ciltacabtagene autoleucel), looks set for approval in Europe after endorsement by regulators for advanced multiple myeloma. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use recommended Carvykti for adults with relapsed and refractory disease who have received at least three prior therapies and whose cancer has worsened since their last treatment.
Janssen Pharmaceutical Cos, Inc.’s CAR T-cell therapy, Carvykti (ciltacabtagene autoleucel), looks set for approval in Europe after endorsement by regulators for advanced multiple myeloma. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use recommended Carvykti for adults with relapsed and refractory disease who have received at least three prior therapies and whose cancer has worsened since their last treatment.
Janssen Pharmaceutical Cos. Inc. has become the second company to get a BCMA-targeting CAR T therapy to market with the approval of ciltacabtagene autoleucel for adults with relapsed or refractory multiple myeloma (MM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
