The accelerated approval was based on data from two phase 2 trials: the ROAR basket study and the NCI-MATCH Subprotocol H study.
Approval was based on data from the phase 3 KEYNOTE-716 trial, which enrolled 976 participants.
In 2019, the FDA granted accelerated approval to Tecentriq, a PD-L1 blocking antibody, for unresectable locally advanced or metastatic TNBC.
The approval is indicated for individuals 16 years of age and older, however the vaccine remains available to those aged 12 years and older under the EUA.
The approval was based on data from the open-label, multi-cohort phase 2 UNITY-NHL Trial.
Results presented at the European Society for Medical Oncology Virtual Congress 2020showed significant improvements in the primary endpoints for the pembrolizumab group.
Approval was based on results from two phase 2 single-arm, open-label trials that demonstrated overall response rate and duration of response.