Article

FDA Grants Accelerated Approval to Astellas

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.

Newsletter

Stay up to date on cancer updates, research and education

Related Videos
Image of doctor.
Image of man.
Image of man with black hair.
Image of man.
Dr. Guru Sonpavde emphasized the importance of better understanding how genetic mutations influence the treatment of cancer care, particularly GU cancers.
Dr. Park sat down for an interview with CURE® to discuss the key takeaways from the 2025 Annual ASCO Genitourinary Cancers Symposium.
Image of man with black hair.
Dr. Petros Grivas discusses what precautions should be considered when treating patients with advanced urothelial carcinoma who have diabetes.
Primary urothelial cancer has variable histologies, making its treatment complex, leading to varied outcomes with high rates of recurrence in patients.
Image of bald man.
Related Content