High response rates reported by GSK and iTeos at the 2024 European Society for Medical Oncology Congress offer a ray of light for anti-TIGIT therapies after a string of failures.
The result comes months after an FDA advisory committee flagged the risk of potential overtreatment with perioperative regimens.
Friday’s approval comes after a previous rejection in October 2023 due to manufacturing concerns.
The expanded capacity will help the drugmakers meet the demand for Beyfortus ahead of the RSV season. The therapy was in tight supply last year.
The company is trying to increase doctor awareness of and testing for a rare lung cancer mutation to help boost use of its drug Braftovi, which the pharmaceutical maker anticipates could grow to become the standard of care.
Yesterday the FDA issued an alert about Astellas’ Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, stating that it can cause rare but serious liver injury. The agency stated that if there are signs and symptoms suggesting liver injury, halting use of the medicine could prevent worsening liver injury and potentially return liver function to normal.