The U.S. Food and Drug Administration granted accelerated approval of Gilead Sciences Inc.’s Trodelvy (sacituzumab govitecan-hziy) for use in adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 or a programmed death-ligand 1 inhibitor.
Six former FDA commissioners – Scott Gottlieb, Robert Califf, Mark McClellan, Margaret Hamburg, Jane Henney and Andrew von Escehenbach – signed a joint letter urging the U.S. president to nominate a permanent commissioner soon.
The U.S. Food and Drug Administration granted Roche’s Venclexta (venetoclax) full approval in combination with azacytidine, or decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia in adults 75 years or older.
Immunomedics Inc.’s cancer drug Trodelvy, which received accelerated U.S. regulatory approval in April 2020, extended survival time in previously treated patients with an advanced form of breast cancer in a clinical trial.
The U.S. Food and Drug Administration granted accelerated approval for NS Pharma’s Viltepso (viltolarsen) injection for patients with Duchenne muscular dystrophy who are amenable to exon 53 skipping therapy.
The U.S. Food and Drug Administration granted accelerated approval to Gilead Company Kite’s Tecartus (brexucabtagene autoleucel, formerly KTE-X19) as the first approved chimeric antigen receptor T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
The U.S. Food and Drug Administration approved Jazz Pharmaceuticals and company partner PharmaMar’s Zepzelca (lurbinectedin) for adults with metastatic small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy.
The U.S. Food and Drug Administration approved Clovis Oncology Inc.’s Rubraca (rucaparib) tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
Eli Lilly is moving quickly to get the newly approved precision oncology treatment Retevmo for certain lung and thyroid cancers into the hands of patients.
Merck & Co. Inc.’s blockbuster anti-PD-1 immunotherapy Keytruda failed a late-stage trial’s main goals of slowing disease progression and extending the life of patients with a common type of liver cancer.