www.fdanews.com/articles/189508-fda-gives-roches-tecentriq-chemo-combo-priority-review
FDA Gives Roche’s Tecentriq-Chemo Combo Priority Review
December 12, 2018
The FDA granted priority review for Roche’s extensive-stage small cell lung cancer (ES-SCLC) treatment Tecentriq in combination with chemotherapy.
The treatment is intended for first-line treatment of patients with ES-SCLC, and the agency is expected to make a decision on Tecentriq’s approval by March 18, 2019.
Tecentriq has been approved by the FDA to treat patients suffering from metastatic non-small cell lung cancer who have seen the disease progress during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has ALK or EGFR abnormalities.