The FDA is expected to make a decision on approval by June 19, 2020.
“In the IMpower110 study, Tecentriq alone demonstrated a significant improvement in overall survival compared with chemotherapy for people newly diagnosed with certain types of advanced non-small cell lung cancer,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are working closely with the FDA to bring this chemotherapy-free option to these patients as quickly as possible.”
This sBLA is based on results from the Phase III IMpower110 study, which showed that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 months; hazard ratio [HR]=0.595, 95% CI: 0.398–0.890; p=0.0106) in people with high PD-L1 expression (TC3/IC3-WT). Safety for Tecentriq appeared to be consistent with its known safety profile, and no new safety signals were identified. Grade 3-4 treatment-related adverse events (AEs) were reported in 12.9% of people receiving Tecentriq compared with 44.1% of people receiving chemotherapy.
Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
Source: Company Press Release