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Janssen’s Type II Variation for Carvykti (ciltacabtagene autoleucel; Cilta-cel) Receives CHMP’s Positive Opinion to Treat Multiple Myeloma

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Janssen’s Type II Variation for Carvykti (ciltacabtagene autoleucel; Cilta-cel) Receives CHMP’s Positive Opinion to Treat Multiple Myeloma

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  • 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 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

Related News:- Janssen and Legend Biotech Report the sBLA Submission of Carvykti (ciltacabtagene autoleucel) to the US FDA for Relapsed or Refractory Multiple Myeloma

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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