The approval was based on data from a phase 2 trial.
Incyte has withdrawn the NDA for parsaclisib for follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma.
Continued approval required further verification and description of clinical benefit in confirmatory trials.
The HHS added 8 new substances to the 15th Report on Carcinogens, bringing the total list to 256 substances.
The EUA was supported by data from the phase 2/3 EPIC-HR study.
The phase 3 RATIONALE 309 trial was designed to evaluate the efficacy and safety of tislelizumab plus chemotherapy in adults with recurrent or metastatic nasopharyngeal cancer.
The EUA was supported by primary data from the phase 3 PROVENT trial.
The approval was based on data from the open-label, randomized phase 3 Inter-B-NHL Ritux 2010 trial.
Continued approval required further verification and description of clinical benefit in confirmatory trials.
Results showed an overall response rate of 84.8%.
