Andrea Lobo,  —

Sarclisa under FDA priority review as first-line myeloma therapy

The U.S. Food and Drug Administration (FDA) has granted priority review to Sanofi’s application of Sarclisa (isatuximab) in combination with standard of care for treating people newly diagnosed with multiple myeloma who aren’t eligible for a transplant. Priority review is given to therapies that target serious medical conditions…

Abecma OK’d in US to take earlier in treatments for multiple myeloma

The U.S. Food and Drug Administration (FDA) has expanded the indication of Abecma (idecabtagene vicleucel) to allow its use earlier in the therapy regimen for adults with difficult-to-treat multiple myeloma. The CAR T-cell therapy, developed by Bristol Myers Squibb (BMS) and 2seventy bio, was already approved in…

CAR T-cell therapy recommended as earlier treatment line for RRMM

An advisory committee of the U.S. Food and Drug Administration (FDA) has unanimously recommended extending the approval of Janssen’s Carvykti (ciltacabtagene autoleucel) as an earlier line of treatment for adults with relapsed or refractory multiple myeloma (RRMM). The 11 -0 vote by the Oncologic Drugs Advisory Committee was…

Phase 1b trial of STAR-LLD combo for myeloma approved by FDA

The U.S. Food and Drug Administration (FDA) has cleared the launch of a Phase 1b trial to test STAR-LLD, Starton Therapeutics’ experimental continuous delivery of low-dose lenalidomide into the blood, in people with multiple myeloma. The U.S.-based study, expected to start in the last months of the year,…