Padcev (enfortumab vedotin-ejfv) has been granted Breakthrough Therapy designation in the US when used in combination with MDS’s Keytruda (pembrolizumab) for certain bladder cancers, Astellas has announced.

The drug combo is indicated for patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.

Astellas has confirmed that the designation was granted based on results from the dose-escalation cohort and expansion cohort A of the EV-103 Phase Ib/II trial, which evaluated patients with locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy.

The US Food and Drug Administration (FDA) 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,” said Andrew Krivoshik, senior vice president and oncology therapeutic area head, Astellas. “We look forward to continuing our work with the FDA as we progress our clinical development program as quickly as possible.”

The decision is also being hailed as an “important step” in the investigation in to the combination, with Roger Dansey, chief medical officer of Seattle Genetic saying “Based on encouraging early clinical activity, we recently initiated a phase III trial of this platinum-free combination and look forward to potentially addressing an unmet need for patients.”

The FDA’s Breakthrough Therapy process is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition.

Globally, approximately 549,000 people were diagnosed with bladder cancer in 2018, and there were approximately 200,000 deaths worldwide.