This Isn't The Big One: Darzalex Wins US Approval In First-Line Multiple Myeloma
Janssen Biotech has won FDA approval for Genmab-licensed Darzalex in newly diagnosed multiple myeloma. However, the drug was approved in a combination that is not commonly used in the US. A further label expansion will provide a bigger boost to the anti-CD38 antibody's commercial prospects.
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Isatuximab could be the next building block in Sanofi's ambitions to rebuild in oncology. The CD38-targeting antibody extended PFS in relapsed/refractory multiple myeloma in combination with Celgene's Pomalyst and dexamethasone.
Keeping Track: A CRL For Tlando, An Accelerated Approval For AndexXa, And A Burst Of Supplemental Approvals
The latest US drug development news and highlights from our Performance Tracker.
Karyopharm has reported positive top-line Phase IIb data from the STORM study showing the potential benefits of its orally active lead compound, selinexor, in "penta-refractory" multiple myeloma, and is aiming for rapid approval of the first-in-class agent in the US and Europe.