The FDA approves belantamab mafodotin for relapsed or refractory myeloma

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  The US Food and Drug Administration (FDA) has approved belantamab mafodotin (BLENREP) as a monotherapy treatment for adult patients with relapsed or refractory myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This…

Belantamab mafodotin receives positive opinion from the EMA for relapsed and refractory myeloma

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of belantamab mafodotin as monotherapy for the treatment of myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

European Commission grants Marketing Authorisation for subcutaneous daratumumab for all approved intravenous daratumumab indications

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  The European Commission (EC) has granted marketing authorisation for daratumumab (Darzalex®) subcutaneous (SC) formulation for the treatment of adult myeloma patients. Daratumumab SC is administered as a fixed dose, which significantly reduces treatment time, from hours to approximately three to five minutes, when compared to daratumumab intravenous (IV) formulation.

European Commission approves isatuximab for relapsed and refractory myeloma patients

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  The European Commission (EC) has approved isatuximab (Sarclisa®) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adult patients with relapsed and refractory myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.

FDA Refusal to File letter for Idecabtagene Vicleucel (ide-cel, bb2121) for the treatment of myeloma patients

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  Bristol Myers Squibb (BMS) and bluebird bio, Inc have announced that the companies received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pre-treated relapsed and refractory myeloma, which was submitted in March 2020.

Isatuximab receives positive opinion from the EMA for the treatment of relapsed and refractory myeloma patients

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  The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for isatuximab (Sarclisa®). The CHMP recommends this drug in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adult patients with relapsed and refractory myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.