On 10 July 2026, the FDA announced that it approved each of MSD’s Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Astellas’ Padcev® (enfortumab vedotin), as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC). This approval extends the previous US approval for the regimen in this setting from cisplatin-ineligible patients to all patients with MIBC who are candidates for cystectomy.
The FDA’s review of the new Keytruda®/Keytruda Qlex™ indication was conducted under Project Orbis, in collaboration with the regulatory authorities of Australia, Canada, Switzerland, the UK and Israel. The MIBC indication for cisplatin-ineligible patients was recently approved in Europe.
A day earlier, on 9 July 2026, the FDA announced another oncology approval, with Sanofi-Aventis’ Sarclisa Escena™ (isatuximab-irfc), a subcutaneous formulation of Sarclisa®, approved as the first anticancer treatment administered via an on-body injector.
Sarclisa Escena™ is approved in combination with standard-of-care regimens for the treatment of patients with multiple myeloma across all existing indications of the IV formulation of Sarclisa®. The drug may be administered by manual SC administration or via the CirCLIQ® on-body injector.
While isatuximab biosimilars are some way off, pembrolizumab biosimilars are in development including by Samsung Bioepis, Formycon, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene. They have reportedly also been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).