FDA approves review for Bayer’s Aliqopa

Further to positive data from a subgroup of the CHRONOS-1 trial, Bayer’s PI3K inhibitor Aliqopa (copanlisib), for marginal zone lymphoma patients who have received two prior therapies, has been given Breakthrough Therapy Designation by the FDA. The company is undertaking two further phase 3 studies to evaluate the efficacy and safety of copanlisib in combination with other therapies in indolent non-Hodgkin’s Lymphoma patients who have relapsed following one or more prior therapies.
Scott Fields, senior vice president and head of oncology development at Bayer’s Pharmaceutical Division, said: “The clinical evidence suggests that copanlisib may address an unmet medical need by providing physicians and MZL patients with a therapy in a relapsed setting where there are no approved treatments. We will continue working closely with the FDA in order to bring copanlisib to these underserved patients as soon as possible.”