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…
Myeloma
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…
Myeloma Action Month to focus on bringing hope through action
Myeloma Action Month (MAM) is observed each March to call attention to multiple myeloma and the people affected by it, and this year’s…
FDA OKs less frequent Tecvayli dosing for treatment responders
The U.S. Food and Drug Administration (FDA) has cleared an every-other-week dosing regimen of Tecvayli (teclistamab) for relapsed or refractory (hard-to-treat) multiple myeloma…
Elrexfio now approved in Canada as recurring myeloma treatment
Health Canada has granted conditional approval to Pfizer’s Elrexfio (elranatamab-bcmm), expanding the list of countries where the medication can be used for adults with…
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