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Roche Receives CHMP Recommendation for Approval of Columvi (glofitamab) to Treat Relapsed or Refractory Diffuse Large B-Cell Lymphoma in EU

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Roche Receives CHMP Recommendation for Approval of Columvi (glofitamab) to Treat Relapsed or Refractory Diffuse Large B-Cell Lymphoma in EU

Shots:

  • The EMA’s CHMP has recommended the approval of Columvi for adult patients with r/r DLBCL after 2 lines of systemic therapy. The EC’s final decision is expected in the near future
  • The recommendation was based on the pivotal cohort in the P-I/II (NP30179) study evaluating Columvi. The results showed that Columvi given as a fixed course induced a CR (35.2%), ORR (50%) while 74.6% continued to experience a response @12mos. who achieved CR, the median duration of CR (not reached), and the median follow-up for DoR was 12.8mos. & median time to first CR was 42 days
  • 1 patient discontinued treatment due to CRS while the NEJM provided additional data from a larger cohort in the (NP30179) study. Columvi was approved in Health Canada for r/r DLBCL

Ref: Globenewswire | Image: Roche

Related News:- Roche’s Columvi (glofitamab) Receives Health Canada Authorization for the Treatment of Adult Patients with Diffuse Large B-cell Lymphoma

Click here to­ read the full press release 

Senior Editor

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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