(RTTNews) – The U.S. Food and Drug Administration granted Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) accelerated approval in the U.S. as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who are not eligible to receive cisplatin-containing chemotherapy, Seagen Inc. (SGEN) and Astellas Pharma Inc. said in a statement.
The company noted that the indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in the EV-302 confirmatory trial.
The combination therapy was granted Breakthrough Therapy designation by the FDA in February 2020 based on Dose Escalation/Cohort A data. The combination therapy was also granted Priority Review in December 2022.
The U.S. Prescribing Information for Padcev includes a BOXED WARNING for Serious Skin Reactions as well as certain Warnings and Precautions: hyperglycemia, pneumonitis/interstitial lung disease, peripheral neuropathy, ocular disorders, infusion site extravasation, and embryo-fetal toxicity.
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