BMS Reports EMA's Validation of Type II Variation Application for Breyanzi (lisocabtagene maraleucel) to Treat R/R Large B-cell Lymphoma
Shots:
- The application was based on the P-III (TRANSFORM) study evaluating Breyanzi vs SoC in adults with r/r LBCL who are refractory or relapsed within 12mos. of initial therapy & are candidates for HSCT. With the validation, the submission is complete & the EMA will now initiate the review procedure
- The results showed an improvement in the EFS, CR rates & PFS, well-established safety profile with very low rates of sev. CRS & neurologic events & no new safety signals were identified. The results were consistent with Breyanzi in the 3L+ setting
- Breyanzi’s sBLA is currently under the US FDA’s Priority Review for r/r LBCL with an anticipated PDUFA date of June 2022 while the Breyanzi's NDA is also under MHLW’s review for the 2L treatment of r/r LBCL
Ref: Bussinesswire | Image: BMS
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