Multiple studies at the 65th American Society of Hematology Annual Meeting 2023 have the potential to change the treatment paradigm for first-line treatment of multiple myeloma.
Three giants have produced new phase III study data for their already approved, big name therapies. Two were positive and the third was stopped for futility.
The latest global regulatory news, changes and updates affecting biopharma, including: The other shoe drops for former Insys CEO; NICE gives nod to new myeloma regimen; MHRA prepares for January; FDA guidances finalized.
DUBLIN – Novartis AG, Bristol Myers Squibb Co. and Sanofi SA were among firms that secured positive opinions from EMA’s Committee for Medicinal Products for Human Use (CHMP) on marketing authorization applications for new therapies, which will progress to formal approvals 67 days from now. Because of the COVID-19 pandemic, the committee’s March meeting was held virtually.
Paris-based Sanofi SA won FDA clearance of the intravenously given CD38-directed cytolytic antibody Sarclisa (isatuximab-irfc) in combination with pomalidomide (Pomalyst, Celgene Corp.) and dexamethasone (dex) for adults with multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide (Revlimid, Celgene Corp.) and a proteasome inhibitor.