FDA Approves Rituxan Plus Chemotherapy for Certain Pediatric Hematologic Cancers
The approval was based on data from the open-label, randomized phase 3 Inter-B-NHL Ritux 2010 trial.
The approval was based on data from the open-label, randomized phase 3 Inter-B-NHL Ritux 2010 trial.
Cytalux is a fluorescent drug intended to assist surgeons in identifying ovarian cancer lesions.
The approval is supported by data from the phase 3 BEACON CRC trial.
The approval was based on data from the phase 2 innovaTV 204 trial that evaluated Tivdak as monotherapy in 101 women with recurrent or metastatic cervical cancer.
The approval was based on data from the phase 3 COSMIC-311 study.
Exkivity (mobocertinib) is approved to treat adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
The approval was based on data from the phase 3 ASPEN trial.
The full approval was based on data from the confirmatory phase 3 KEYNOTE-361 trial.
In 2019, the FDA granted accelerated approval to Tecentriq, a PD-L1 blocking antibody, for unresectable locally advanced or metastatic TNBC.
The approval was based on data from the double-blind, placebo-controlled ClarIDHy study.