Shots:
- The positive opinion was granted by CHMP based on the results from the P-III (CARTITUDE-4) clinical trial evaluating the safety & efficacy of Carvykti vs Standard Therapy (Pomalidomide, Bortezomib & Dexamethasone (PVd)/Daratumumab, Pomalidomide and Dexamethasone (DPd)) in patients with r/lenalidomide-r multiple myeloma
- Patients in the trial have previously received 1-3 prior lines of therapy, depicted disease progression on the last therapy & were refractory to lenalidomide
- Carvykti is a BCMA-directed genetically modified autologous T-cell immunotherapy that has received a CMA from the EMA in May 2022 & approval from the US FDA in Feb 2022 for the treatment of r/r MM
Ref:Johnson & Johnson | Image: Johnson & Johnson| Press Release
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