US FDA approval based on 98 percent response rate in multiple myeloma patients treated once with Carvykti (ciltacabtagene autoleucel, cilta-cel).
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relapsed refractory multiple myeloma (RRMM)
Melfufen met the primary endpoint of superior progression free survival (PFS) with a median of 6.8 months in Phase III OCEAN trial.
The European Commission (EC) has approved Abecma, the first anti-BCMA CAR T-cell therapy for patients with multiple myeloma.
Drugs recommended for approval by the European Medicines Agency’s human medicines committee included a gene therapy and two generics, among five others.
New trial data shows 98 percent of heavily pre-treated relapsed/refractory multiple myeloma patients responded to Janssen’s ciltacabtagene autoleucel (cilta-cel).
New Phase I data shows 65 percent of triple-class and 83 percent of penta-drug refractory multiple myeloma patients responded to talquetamab.
BMS and bluebird bio have applied to the FDA for approval of ide-cel as a standard therapy for relapsed or refractory multiple myeloma based on positive Phase II trial results.
The committee for human medicinal products recommended AstraZeneca’s COVID-19 vaccine be granted conditional marketing authorisation alongside 12 other approvals.
The European Commission granted the conditional marketing authorisation (CMA) based on data from a trial in which Blenrep achieved an overall response rate of 32 percent.
European Pharmaceutical Review investigates five of the latest cancer drug approvals and clinical trial results.
An investigational CT053 CAR-T cell therapy for RRMM has been given Regenerative Medicine Advanced Therapy designation.
Accelerated approval has been granted to Xpovio to treat refractory multiple myeloma by the FDA.