CAR T-cell therapy anito-cel set for Phase 3 trial in multiple myeloma
Arcellx and Kite Pharma are planning to launch a Phase 3 clinical trial, dubbed iMMagine-3, to test their cell therapy anitocabtagene…
News
CAR T-cell therapy NXC-201 given orphan drug status in EU
NXC-201, an investigational CAR T-cell therapy, has been designated an orphan drug in the European Union (EU) as a potential treatment of multiple myeloma.
15th annual International Myeloma Foundation gala raises over $675K
At its 15th annual gala, held in New York City this April, the International Myeloma Foundation (IMF) raised more than $675,000 — monies the…
FDA committee votes 12-0 for myeloma trial outcome measure
A unanimous vote by a committee of the U.S. Food and Drug Administration (FDA) could lead to an early outcome measure — one known as…
CAR T-cell therapy Carvykti OK’d as second-line RRMM treatment
The U.S. Food and Drug Administration (FDA) has approved the CAR T-cell therapy Carvykti (ciltacabtagene autoleucel) as a second line of treatment for adults…
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…
Steroid-free Venclexta combo shows promise in myeloma cells
Combining the cancer therapy Venclexta (venetoclax) with a molecule called 5-azacytidine (5-aza) increased the former’s ability to kill lab-grown cancer cells derived from a range…
Abecma cleared in EU as earlier therapy for hard-to-treat myeloma
The European Commission has approved Bristol Myers Squibb (BMS)’s request to expand the use of the CAR T-cell therapy Abecma (idecabtagene vicleucel) as…
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…
Approval of a Darzalex Faspro therapy combo is sought in Europe
Johnson & Johnson has applied to the European Medicines Agency (EMA) for approval of its under-the-skin formulation of Darzalex (daratumumab), called…
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