LAUSR

2020 include US approval decisions for enfortumab vedotin for urothelial cancer, AR101 for peanut allergy and ozanimod for multiple sclerosis. Astellas and Seattle Genetics are developing enfortumab vedotin for the treatment of urothelial cancer. This antibody– drug conjugate (ADC) targets nectin-4, a cell adhesion molecule overexpressed in solid tumours. In February 2019, longterm results from a phase I trial of enfortumab vedotin in patients with metastatic urothelial cancer showed an encouraging confirmed overall response rate (ORR) of 42% and a 7.7-month median duration of response (DoR) among responders to treatment. Additional results from the phase II EV-201 study showed a similar ORR of 44%, with complete responses observed in 12% of treated patients and a median DoR of 7.6 months. Owing to the high unmet need in this area, these positive results significantly increased enfortumab vedotin’s likelihood of approval. A biologics license application (BLA) for enfortumab vedotin was subsequently submitted to the FDA in July 2019 for patients who have locally advanced or metastatic urothelial cancer after being treated with a PD1/PDL1 inhibitor or platinumcontaining chemotherapy. A decision from the FDA is due by the Committee (APAC) convened by the FDA voted in favour of approval for AR101 in September 2019, increasing its already high chance of approval. If approved, AR101 would be the first treatment on the market for peanut allergy. In addition, AR101 has been studied in Europe in a phase III trial known as ARTEMIS. Positive results were also reported, with 58% of patients who received AR101 tolerating 1,000 mg of peanut protein, reinforcing the efficacy data from PALISADE and adding support for regulatory applications outside the United States.