FDA approves Tibsovo + Vidaza in IDH1-mutant newly diagnosed AML

FDA grants accelerated approval to Enhertu for unresectable or metastatic HER2-positive solid tumors

FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

April 12, 2024

Vol.50 No.15

White House

White House misses deadline to finalize FDA rule banning menthol cigarettes, prompting lawsuit from health groups

A coalition of health and physician groups earlier this week filed a lawsuit seeking to force FDA to finalize a long-delayed final rule banning menthol cigarettes.

FDA approves Abecma for earlier lines of treatment for MM

FDA approved Abecma (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 trial (The Cancer Letter, March 22, 2024).

April 05, 2024

Vol.50 No.14

Regulatory News

Exercising new powers, FDA issues Complete Response Letters based on insufficient enrollment in confirmatory trials

FDA issued Complete Response Letters for the Biologics License Application for odronextamab in relapsed/refractory follicular lymphoma and in R/R diffuse large B-cell lymphoma, each after two or more lines of systemic therapy.

FDA approves Elahere for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

FDA approved Elahere (mirvetuximab soravtansine-gynx) for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

March 29, 2024

Vol.50 No.13