Roche’s Columvi (glofitamab) Receives EC’s Conditional Marketing Authorization for Relapsed or Refractory Diffuse Large B-cell Lymphoma
Shots:
- Columvi has received conditional marketing authorization from the EC for adults with r/r DLBCL. The approval was based on the P-I/II (NP30179) study evaluating Columvi in 860 patients
- The results showed that Columvi gave as a fixed course induced a complete response (35.2%), ORR (50%), 74.6% continued to experience a response at 12mos., the median duration of CR (not reached), median follow-up for DoR (12.8mos.), median time to first CR was 42 days, CRS was low grade (grade 1: 48.1%; grade 2: 12.3%), CRS leading to treatment discontinuation in 1 patient
- Additional study results from a larger cohort reinforce the durability of Columvi. The company continues to expand the clinical development program incl. the P-III trial (STARGLO) of Columvi + GemOx for 2L+ DLBCL
Ref: GlobeNewswire | Image: Roche
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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.
