BRIEF—Bayer nabs Breakthrough status for Aliqopa in marginal zone lymphoma

The US Food and Drug Administration has granted Breakthrough Therapy designation for Aliqopa (copanlisib) for the treatment of adult patients with relapsed marginal zone lymphoma (MZL) who have received at least two prior therapies.

MZL is an indolent form of non-Hodgkin's Lymphoma (iNHL) and accounts for about 10% of all non-Hodgkin's Lymphoma in the USA.

German pharma major Bayer’s Aliqopa is an intravenous phosphatidylinositol-3-kinase (PI3K) inhibitor with inhibitory activity predominantly against the PI3K-alpha and PI3K-delta isoforms expressed in malignant B cells. The compound is currently not approved by the European Medicines Agency (EMA) or other authorities outside of the USA, where it was approved in 2017.

"The clinical evidence suggests that Aliqopa may address an unmet medical need by providing physicians and MZL patients with a therapy in a relapsed setting," said Dr Scott Fields, senior vice president and head of oncology development at Bayer's Pharmaceutical Division. "We will continue working closely with the FDA in order to bring Aliqopa to these underserved patients as soon as possible."

Bayer is conducting two additional Phase III studies – CHRONOS-3 and CHRONOS-4 – to evaluate the efficacy and safety of Aliqopa in combination with other therapies for those with iNHL (including MZL) who have relapsed following one or more prior therapies.