The phase III IMpassion131 study evaluating Tecentriq in combination with paclitaxel (chemotherapy), in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-free survival for the initial (first-line) treatment of people with metastatic triple-negative breast cancer, in the PD-L1-positive population.
The Oncologic Drugs Advisory Committee held its first session since President Trump’s inauguration, with a two-day, back-to-back marathon meeting, signaling a return to business at FDA after significant upheaval at the agency.
