The sBLA is based on the results from the confirmatory EV-302 trial which found the combination therapy to significantly prolong overall survival and progression-free survival, compared to standard platinum containing chemotherapy
Astellas Pharma and Seagen have secured priority review from the US Food and Drug Administration (FDA) for their supplemental biologics license application (sBLA) for using the Padcev (enfortumab vedotin-ejfv) and Keytruda (pembrolizumab) combination as first-line treatment of certain form of advanced bladder cancer.
The FDA has set 9 May 2024 as the target action date under the Prescription Drug User Fee Act (PDUFA).
If approved, the combination treatment will become the first option for cisplatin eligible and ineligible patients.
In April 2023, the FDA granted accelerated approval for the combination’s use in treating adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). The approval was based on the tumor response rate and durability of response observed in the Phase 3 EV-103 trial for individuals ineligible for cisplatin-containing chemotherapy.
Seagen research and development president Roger Dansey said: “The FDA’s acceptance of our application is a critical step in our work as we seek to deliver this combination to more patients who currently have few treatment options at the advanced stage.”
The sBLA is based on the results from the Phase 3 confirmatory EV-302 clinical trial featuring 886 patients.
In comparison to platinum-containing chemotherapy, the combination therapy was observed to enhance overall survival (OS) and progression-free survival (PFS) in patients with previously untreated la/mUC.
There were no new safety concerns found, and the safety results were in line with those that had previously been reported with the combination regimen.
Astellas Pharma senior vice president and oncology development head Ahsan Arozullah said: “We look forward to the FDA’s review of this application, which, if approved, will convert the accelerated approval of the combination based on results from the EV-103 study to standard approval for all first-line locally advanced or metastatic urothelial cancer patients, expanding the indication to cisplatin eligible patients.”
In a separate development, Astellas Pharma has entered into a research partnership with Phenomic AI through its wholly owned subsidiary, Xyphos Biosciences.
Under the partnership, the parties will assess the ways to improve cell therapy methods for treating solid tumours by using antibodies.
The collaboration will use antibodies developed by Phenomic AI and directed at a new target of the tumour stroma found using the company’s scTx platform.
Phenomic AI will be eligible for milestone payment, research funds, and an upfront payment. On the other hand, Astellas Pharma will have the first right to negotiate a license for the antibodies.