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...
In-Person US FDA Meetings Returning? Agency Will Support Those Events At HQ
A workshop broadcast from White Oak was a shift from the fully virtual meetings held since the height of the COVID-19 pandemic and may be a step toward once again staging public events there.
Keeping Track: US FDA Approves Korsuva, Skytrofa And Comirnaty, But Tecentriq Loses TNBC Indication
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Keytruda TNBC Approval Now More Likely, But Data Is Bad News For pCR Surrogate Endpoint
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.