Janssen Initiates Rolling Submission of BLA to US FDA of Autoleucel (cilta-cel) to Treat Multiple Myeloma

December 23, 2020 Auto Bot BLA, Initiates, Janssen, multiple myeloma, regulatory, Submission, Us FDA 0

Shots:

  • Janssen Initiates Rolling Submission of BLA to US FDA is based on P-lb/ll CARTITUDE-1 Study involve evaluating the safety and efficacy of Autoleucel (cilta-cel) in adults for the treatment of relapsed and refractory Multiple Myeloma
  • The FDA granted BTD for cilta-cel and agreed to BLA’s rolling review includes completed portions of the application to be submitted and reviewed on an ongoing basis and the data were presented at the 62nd (ASH) Annual Meeting
  • Cilta-cel is a unique, structurally differentiated CAR-T cell therapy containing a 4-1BB co-stimulatory domain and 2 BCMA-targeting single-domain antibodies with a preferential CD8+ T-cell expansion

Click here ­to­ read full press release/ article | Ref: Janssen  | Image: Apotheke Adhoc

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