FDA has given an accelerated approval to Padcev in the treatment of patients with locally advanced or metastatic urothelial cancer.
The U.S. Food and Drug Administration announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to PADCEV™ for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.
PADCEV is approved under the FDA’s Accelerated Approval Program based on tumor response rate.
Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
Read Seattle Genetics’ and Astellas’s press release here.
FDA Approves 3 Treatments, Cancer Vaccine Shows Promise
December 20th 2023The Food and Drug Administration recently approved treatment for some patients with neuroblastoma, kidney cancer and bladder cancer. Elsewhere, a cancer vaccine made headlines for the treatment of patients with melanoma.
Listen
Olivia Munn Discusses Breast Cancer, Christine Brinkley Diagnosed With Basal Cell Carcinoma and More
March 15th 2024From Oliva Munn and Christine Brinkley discussing their cancer to Donnie Iris returning to the stage after his experience with the disease, here is what’s happening in the oncology space this week.
Read More
FDA Approves Opdivo Plus Chemo for Unresectable or Metastatic Bladder Cancer
March 7th 2024The Food and Drug Administration (FDA) has approved Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adults with unresectable or metastatic bladder cancer, the agency has announced.
Read More