The trial, which is the first to be implemented under Operation Warp Speed, is expected to enroll around 30,000 adults and will be conducted at multiple clinical research sites across the US.
The FDA has approved Zepzelca™ (lurbinectedin; Jazz Pharmaceuticals) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
The FDA has approved a new ready-to-dilute liquid formulation of Akynzeo® injection (fosnetupitant/palonosetron; Helsinn) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, in combination with dexamethasone in adults.
The FDA has approved Cyramza (ramucirumab; Lilly) in combination with erlotinib, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
Specifically, unacceptable levels of this potentially carcinogenic impurity have been identified in products manufactured by 5 different firms.
This indication was granted accelerated approval based on overall response rate (ORR) and continued approval may be contingent upon confirmatory trial results.
The FDA has approved the combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
The FDA has approved Lynparza® for use in combination with bevacizumab as first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer
The FDA has granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy; Immunomedics) for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least 2 prior therapies for metastatic disease.
The FDA has approved Tukysa (tucatinib; Seattle Genetics), in combination with trastuzumab and capecitabine, for treatment of adult patients with advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer, including patients with brain metastases, who have received 1 or more prior anti-HER2-based regimens in the metastatic setting.
