Adcetris gets speedy label expansion under FDA real-time pilot

FDA approved a label expansion for Adcetris brentuximab vedotin less than two weeks after Seattle Genetics Inc. (NASDAQ:SGEN) submitted the sBLA. The agency said Adcetris is the first U.S.-approved treatment for newly diagnosed peripheral T-cell lymphoma (PTCL), and the second drug approved through FDA's Real-Time Oncology Review (RTOR) program.

The RTOR pilot program allows FDA to access key data and begin reviewing supplemental indications of approved cancer drugs before a sponsor's official submission. The agency's first approval via RTOR, a label expansion for Kisqali ribociclib from Novartis AG (NYSE:NVS; SIX:NOVN), took less than three weeks (see "FDA Real-Time Pilot Speeds Kisqali Label Expansion")...