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BMS Reports EMA's Validation of Type II Variation Application for Breyanzi (lisocabtagene maraleucel) to Treat R/R Large B-cell Lymphoma

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BMS Reports EMA's Validation of Type II Variation Application for Breyanzi (lisocabtagene maraleucel) to Treat R/R Large B-cell Lymphoma

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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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