EC Approves Merck and Astellas/Pfizer’s Bladder Cancer Combo

Merck & Co, known outside the US and Canada as MSD, and Astellas/Pfizer have received approval from the European Commission (EC) for their drugs Keytruda (pembrolizumab) and Padcev (enfortumab vedotin) as a first-line combination treatment for advanced bladder cancer. This new combination therapy targets unresectable or metastatic urothelial carcinoma (UC) in adults who are eligible for platinum-containing chemotherapy.

This recent green light from the EC follows a recommendation from the European Medicines Agency’s human medicines committee. The approval is backed by positive results from the late-stage KEYNOTE-A39/EV-302 trial. The trial demonstrated that the combination of Keytruda and Padcev offers a median overall survival of 31.5 months, nearly double the 16.1 months observed with platinum-containing chemotherapy alone. Furthermore, the combination significantly extended progression-free survival, with patients experiencing 12.5 months compared to 6.3 months with chemotherapy.

Bladder cancer ranks as the fifth most commonly diagnosed cancer in Europe, with over 165,000 new cases annually. Keytruda is not a new player in the EU market; it is already approved as a monotherapy for locally advanced or metastatic UC in adults who have previously undergone platinum-containing chemotherapy, as well as for those who are ineligible for cisplatin-containing chemotherapy. Padcev, on the other hand, is indicated as a monotherapy for adults with locally advanced or metastatic UC who have been treated previously with a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor.

Ahsan Arozullah, senior vice president and head of oncology development at Astellas, expressed his optimism about the approval, pointing out the collaborative efforts with clinical trial investigators, study participants, their families, and the broader bladder cancer community. He stated, “This approval is testament to our ongoing partnership... We look forward to patients across the EU gaining benefit from this combination early in their treatment journey.”

In addition to this, Merck’s pulmonary arterial hypertension (PAH) therapy, Winrevair (sotatercept), was also approved in the latest round of EC approvals. Winrevair is slated for use in combination with other PAH therapies to improve exercise capacity in adults with World Health Organization functional classes two to three. This marks it as the first and only activin signaling inhibitor therapy for PAH approved in all 27 EU member states, including Iceland, Liechtenstein, and Norway.

The approval of these significant therapies highlights the ongoing advancements in cancer and hypertension treatments, offering new hope and improved outcomes for patients across Europe.