News

Abecma May Be Effective Early Therapy for Hard-to-treat Myeloma

Note: This story was updated Sept. 26, 2022, to correct the fact that Abecma is approved for patients in Europe and Japan who have undergone at least three prior therapies, not four as originally stated.  The CAR T-cell therapy Abecma (idecabtagene vicleucel) significantly extended survival without signs of disease worsening…

Nexpovio Triple Combo Approved as Myeloma Treatment in Europe

The European Commission has granted full approval to a triple combination therapy of Nexpovio (selinexor) — sold in the U.S. as Xpovio —  to treat adults with multiple myeloma who have received at least one previous line of therapy. The approval covers Nexpovio in combination with Velcade (bortezomib)…

Tecvayli Recommended for Conditional Approval in Europe

A branch of the European Medicines Agency (EMA) has recommended that Janssen’s investigational therapy Tecvayli (teclistamab) be granted conditional marketing authorization for adults with relapsed and refractory multiple myeloma (RRMM). The recommendation, from the EMA’s Committee for Medicinal Products for Human Use (CHMP), specifically supports Tecvayli for patients…

Pepaxti Combo Favored to Treat Advanced Multiple Myeloma in EU

Oncopeptides received a positive opinion from an arm of the European Medicines Agency (EMA) that is expected to take the company one step closer toward European Union approval to market Pepaxti (melphalan flufenamide, also called melflufen) in combination with dexamethasone for hard-to-treat multiple myeloma. With the Committee for Medicinal…

Talquetamab Named a Breakthrough Therapy for Hard-to-treat Myeloma

Talquetamab, a first-in-class antibody treatment being developed by Janssen Research & Development, has been granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for hard-to-treat multiple myeloma. The designation was awarded based on the positive safety and efficacy findings of a Phase 1/2 clinical trial involving adults…

1st CAR T-Cell Therapy in China for Myeloma Now Under Review

The China National Medical Products Administration (NMPA) has agreed to review an application for Equecabtagene autoleucel — the country’s first chimeric antigen receptor (CAR) T-cell therapy — for relapsed or refractory multiple myeloma. The CAR T-cell therapy, the first to be developed domestically in China, was awarded breakthrough…