PADCEV, KEYTRUDA combination : Astellas Pharma and Seattle Genetics said that the combination of PADCEV (enfortumab vedotin-ejfv) and Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) has been given breakthrough therapy designation from the US Food and Drug Administration (FDA) in first-line advanced bladder cancer.

The FDA breakthrough therapy status for PADCEV, KEYTRUDA combination is for the treatment of patients having unresectable locally advanced or metastatic urothelial cancer (bladder cancer) who cannot be given cisplatin-based chemotherapy in the first-line setting.

The FDA grants the breakthrough therapy status to accelerate the development and review of drugs that are intended for the treatment of a serious or life-threatening disorder. The designation is given on the basis of preliminary clinical evidence that suggests that the drug could deliver considerable improvement over existing therapies on one or more clinically significant endpoints.

Andrew Krivoshik – Senior Vice President and Oncology Therapeutic Area Head at Astellas Pharma, commenting on the PADCEV, KEYTRUDA combination 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.

“We look forward to continuing our work with the FDA as we progress our clinical development program as quickly as possible.”

The FDA granted the breakthrough therapy designation for the PADCEV, KEYTRUDA combination based on the data from the dose-escalation cohort and expansion cohort A of the phase 1b/2 trial, EV-103.

The early-stage clinical trial evaluated patients having locally advanced or metastatic urothelial cancer who cannot be given cisplatin-based chemotherapy. Patients enrolled in the clinical trial were treated in the first-line setting with the PADCEV, KEYTRUDA combination.

Roger Dansey – Chief Medical Officer of Seattle Genetics 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.

“Based on encouraging early clinical activity, we recently initiated a phase 3 trial of this platinum-free combination and look forward to potentially addressing an unmet need for patients.”

Recently, Astellas Pharma and Seattle Genetics bagged accelerated approval from the US Food and Drug Administration (FDA) for PADCEV for the treatment of advanced urothelial cancer, the most common form of bladder cancer. Read more about PADCEV FDA approval here.

  Andrew Krivoshik, Astellas Pharma, bladder cancer, cancer, Food and Drug Administration, Keytruda, Merck, Oncology, pembrolizumab, Seattle Genetics, urothelial cancer, US Food and Drug Administration