Genentech’s Tecentriq Should Keep Its Accelerated Approval In Breast Cancer For Now, ODAC Says
Although US FDA panelists said that ideally a new confirmatory trial would be conducted in the same triple-negative breast cancer population, they acknowledged the sponsor’s feasibility concerns and suggested instead that the IMpassion132 trial, expected to report in 2023, might suffice.
You may also be interested in...
Merck unveiled event-free survival results for Keytruda in triple-negative breast cancer following failure earlier this year to gain approval on a surrogate endpoint.
Merck & Co. unveiled event-free survival data for Keytruda in triple-negative breast cancer, following a failure earlier this year to gain approval on a surrogate endpoint.
Stakeholders believe virtual meetings should remain an option going forward, but that in-person sessions should still be convened in many cases.