Merck & Co’s – known as MSD outside the US and Canada – Keytruda (pembrolizumab) and Astellas/Pfizer’s Padcev (enfortumab vedotin) have been approved by the European Commission (EC) as a first-line combination treatment for advanced bladder cancer.
The anti-programmed death receptor-1 therapy/antibody-drug conjugate combination has been authorised to treat unresectable or metastatic urothelial carcinoma (UC) in adults who are eligible for platinum-containing chemotherapy.
The approval follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the late-stage KEYNOTE-A39/EV-302 trial, in which Keytruda plus Padcev resulted in a median overall survival of 31.5 months compared to 16.1 months with platinum-containing chemotherapy.
The combination also significantly extended progression-free survival compared to chemotherapy, at 12.5 months versus 6.3 months.
Bladder cancer is the fifth most commonly diagnosed cancer across Europe, with more than 165,000 new cases every year.
Keytruda is already approved in the EU as a monotherapy for locally advanced or metastatic UC in adults who have received prior platinum-containing chemotherapy and for adults who are not eligible for cisplatin-containing chemotherapy, while Padcev is indicated in the EU as a monotherapy for adults with locally advanced or metastatic UC who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor.
Commenting on the latest authorisation, Ahsan Arozullah, senior vice president and head of oncology development at Astellas, said: “This approval is testament to our ongoing partnership with clinical trial investigators, study participants and their families, and the broader bladder cancer community.
“We look forward to patients across the EU gaining benefit from this combination early in their treatment journey.”
Merck’s pulmonary arterial hypertension (PAH) therapy was also included in the latest round of EC approvals.
Winrevair (sotatercept) was authorised for use in combination with other PAH therapies to improve exercise capacity in adults with World Health Organization functional classes two to three, making it the first and only activin signalling inhibitor therapy for PAH approved in all 27 EU member states, as well as Iceland, Liechtenstein and Norway.