FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Bayer’s Aliqopa Snags Breakthrough Designation for Rare Lymphoma

June 6, 2019

The FDA handed Bayer breakthrough therapy designation for Aliqopa (copanlisib), a kinase inhibitor previously cleared by the agency to treat adults with relapsed follicular lymphoma who have tried two or more prior systemic therapies.

The new designation is for treating relapsed marginal zone lymphoma (MZL) in adults who have received at least two prior therapies. The rare disease makes up approximately 10 percent of all non-Hodgkin’s Lymphoma cases in the U.S.

Data from the drugmaker’s pivotal Phase 2 trial — which led to the drug’s accelerated approval in the U.S. for follicular lymphoma — was cited as a catalyst for the breakthrough designation.

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,” said Scott Fields, head of oncology development at Bayer’s Pharmaceutical Division.

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