The approval was based on data from the phase 3 KEYNOTE-355 trial that pembrolizumab plus chemotherapy in adults with locally recurrent inoperable or metastatic TNBC, who had not been previously treated with chemotherapy in the metastatic setting.
Topline results from the trial showed that compared with chemotherapy, treatment with cemiplimab-rwlc reduced the risk of death by 32% in the overall trial population.
The sNDA is supported by data from the phase 3 ADAURA trial that assessed osimertinib vs placebo in 682 patients with early-stage EGFRm NSCLC after complete tumor resection with or without adjuvant chemotherapy.
The full approval was based on efficacy and safety data from the phase 3 VIALE-A (M15-656) and VIALE-C (M16-043) studies.
The FDA’s accelerated approval of the PARP inhibitor rucaparib brings clinical prostate oncology into the precision medicine era.
Findings showed atezolizumab in combination with paclitaxel did not meet statistical significance for progression free survival and also demonstrated a negative trend in overall survival.
The FDA has approved Gavreto™ (pralsetinib; Blueprint Medicines and Genentech) for the treatment of adults with metastatic RET fusion-positive NSCLC.
The approval was based on data from the multicenter, double-blind, placebo-controlled phase 3 IMspire150 study.
The administration of cedazuridine with decitabine prevents the degradation of decitabine by CDA in the gastrointestinal tract and liver increasing its systemic exposure.
The FDA has approved Phesgo™ (pertuzumab, trastuzumab, hyaluronidase-zzxf; Genentech), in combination with chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer.
