EMA' Advisory Committee Recommends Approval For Roche's Two Cancer Drugs

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended conditional approval for Roche Holdings AG's 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.