The U.S. Food and Drug Administration granted Seagen Inc. and Astellas Pharma Inc.’s Padcev (enfortumab vedotin-ejfv) regular approval in the United States, in addition to approving a new indication for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
Eli Lilly will apply for U.S. health regulator’s accelerated approval during 2021 for the company’s experimental Alzheimer’s drug, weeks after Biogen Inc.’s controversial drug for the disease was approved.
A third member of the U.S. Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee resigned in protest over the regulatory agency’s approval of Biogen’s Aduhelm (aducanumab) for Alzheimer’s disease.
Moderna Inc. on June 1 filed for full U.S. approval of the company’s Covid-19 vaccine, becoming the second drugmaker to do so after Pfizer Inc. and its German partner BioNTech SE sought full clearance for their vaccine in May.
The U.S. Food and Drug Administration approved Truseltiq (infigratinib) under the accelerated approval program for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement.
The U.S. Food and Drug Administration granted approval to Myfembree, Myovant Sciences and Pfizer’s once-daily treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women. Patients receiving the therapy under the newly approved indication can take the medicine for up to 24 months.
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee did not agree in a meeting to maintain the accelerated approval of Bristol Myers Squibb’s Opdivo (nivolumab) as a second-line treatment of hepatocellular carcinoma.
A U.S. Food and Drug Administration committee gave the nod to continue using Genentech’s checkpoint inhibitor Tecentriq in combination with chemotherapy to treat adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.
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.