The FDA has granted acceptance to Merck’s application for the popular drug Keytruda, in combination with standard-of-care chemotherapy (gemcitabine plus cisplatin), for the treatment of biliary tract cancer (BTC). The application is supported by data from the phase 3 KEYNOTE-966 trial involving 1,069 patients, which demonstrated that Keytruda significantly improved survival compared to chemotherapy alone. A decision on the expanded label is expected by February 7, 2024. This combination therapy would be applicable to patients with locally advanced unresectable or metastatic BTC, which accounts for approximately 15% of liver cancer cases. Merck estimates that around 211,000 individuals are diagnosed with BTC annually.
After receiving a complete response letter (CRL) from the FDA for its bimekizumab application, UCB has now obtained two label expansions in Europe for the IL-17A and IL-17F inhibitor. The European Commission has endorsed Bimzelx for the treatment of psoriatic arthritis (PsA) and active axial spondyloarthritis (axSpA). This follows the approval of the treatment for plaque psoriasis in Europe two years ago. The FDA had previously rejected the application in May 2022, citing the need to resolve pre-approval inspection observations. UCB resubmitted the application in December, and a decision is expected soon.
Just five weeks after receiving approval in the US, GSK has obtained approval in Europe for its adult respiratory syncytial virus (RSV) vaccine, Arexvy. The endorsement covers adults aged 60 and older in 30 European countries and is based on a phase 3 study showing overall efficacy of 83%, rising to 95% in older adults with at least one underlying medical condition. The approval arrived earlier than anticipated, following a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) two months prior. This approval will enable GSK to launch the vaccine ahead of the RSV season in the fall. GSK estimates that approximately 270,000 elderly individuals are hospitalized each year due to RSV, with 20,000 deaths.
In late May, Pfizer obtained FDA approval for its RSV vaccine for adults aged 60 and older, while Moderna has conducted a successful phase 3 trial for its RSV vaccine but has not yet submitted an application for approval.
