The breakthrough therapy status enables Padcev plus Keytruda combination to treat patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.
Padcev is a first-in-class antibody-drug conjugate (ADC), which is directed against Nectin-4, a protein situated on the surface of cells and highly expressed in bladder cancer.
Seattle Genetics chief medical officer Dr Roger Dansey said: “This is an important step in our investigation of PADCEV in combination with pembrolizumab as a first-line therapy for patients with advanced urothelial cancer who are unable to receive cisplatin-based chemotherapy.”
The FDA has provided the status based on the data from the dose-escalation cohort and expansion cohort A of the phase 1b/2 trial called EV-103.
The EV-103 is an on-going, multi-cohort, open-label and multicentre phase 1b/2 trial of Padcev alone or in combination, which is assessing safety, tolerability and efficacy in muscle-invasive, locally advanced and first- and second-line metastatic urothelial cancer.
In December 2019, the FDA approved Padcev to treat adult patients with locally advanced or metastatic urothelial cancer who have earlier secured a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.
Seattle Genetics and Astellas are involved in the development of Padcev under an agreement, which was signed in 2007 and expanded in 2009. As per terms of the deal, both firms are sharing costs and profits on a 50:50 basis across the world.
Astellas oncology therapeutic area head senior vice president Dr Andrew Krivoshik said: “The FDA’s Breakthrough Therapy designation reflects the encouraging preliminary evidence for the combination of PADCEV and pembrolizumab in previously untreated advanced urothelial cancer to benefit patients who are in need of effective treatment options.”
Last month, Astellas Pharma signed a deal worth up to $897.5m with Adaptimmune Therapeutics to co-develop and co-commercialise stem-cell derived allogeneic CAR-T and TCR T-cell therapies for cancer.