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