- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended conditional approval for Roche Holdings AG's (OTC:RHHBY) mosunetuzumab for relapsed or refractory (R/R) follicular lymphoma (FL).
- The opinion covers mosunetuzumab for adult patients who have received at least two prior systemic therapies.
- The CHMP recommendation is based on the phase 1/2 GO29781 study results.
- The complete response CR rate was 60%, the objective response rate was 80%, and the median progression-free survival was 17.9 months.
- The median duration of response among those who responded was 22.8 months.
- The CHMP has also backed the approval of Tecentriq (atezolizumab) as an adjuvant treatment, following complete resection and platinum-based chemotherapy, for adults with non-small cell lung cancer (NSCLC).
- The positive opinion comes for patients with a high risk of recurrence whose tumors express PD-L1≥50% and who do not have EGFR mutant or ALK-positive NSCLC.
- The recommendation from the CHMP is based on results from the DFS interim analysis of Phase 3 IMpower010 study. Tecentriq reduced the risk of disease recurrence or death by 57%, compared with best supportive care.
- Price Action: RHHBY shares are up 0.80% at $47.85 during the market session on the last check Friday.
