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CHMP Agenda Includes Hidden Request for Cilta-cel Accelerated Assessment; Precision Issued with a Notice of Allowance for PBCAR19B’s Patent
On Monday, January 25, the CHMP indirectly announced (CHMP agenda) that JNJ / Legend have requested an accelerated assessment for cilta-cel (BCMA CAR-T) in r/r MM, although the documentation only lists the code number for cilta-cel. Additionally, Precision BioSciences announced (press release) that the USPTO has issued a notice of allowance for PBCAR19B, a next-generation CD19 CAR-T. Below, Celltelligence provides insights on how a 1-month delay in filing cilta-cel could result in a 2-month delay for EC approval, an update on ide-cel’s estimated EU approval lead, and the significance of Precision’s latest patent milestone.