Production & Manufacturing
Process & Production

Bayer lymphoma candidate secures FDA priority review designation

PBR Staff Writer Published 18 May 2017

Bayer has secured priority review designation from the US Food and Drug Administration (FDA) for its investigational anti-cancer compound copanlisib to treat follicular lymphoma (FL).

The priority review has been specifically designated for treatment of FL patients whose disease had relapsed or is in the refractory stage and had also received at least two therapies before.

An intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor, copanlisib predominantly inhibits activities of PI3K-α and PI3K-δ isoforms according to Bayer. Copanlisib is to be given to the patients as a 1-hour infusion on a sporadic weekly basis of three weeks on and one week off.

Bayer executive vice president and Strategic Business Unit Head of the Oncology Robert LaCaze said: “Bayer is advancing one of the most diverse oncology portfolios and pipelines and our first priority is to deliver new treatments to cancer patients as quickly and prudently as possible.

“With this milestone, we are one step closer to making copanlisib available in the U.S. to the community of doctors and patients facing a very difficult-to-treat disease in follicular lymphoma.”

Bayer had submitted New Drug Application (NDA) for copanlisib based on the findings recorded from a phase 2 open-label, single-arm trial called CHRONOS-1 carried out in 142 patients. The trial evaluated copanlisib as a monotherapy in patients with relapsed or refractory indolent Non-Hodgkin’s Lymphoma (iNHL) who were previously given at least two treatments for the disease.

Copanlisib had met its primary endpoint of objective response rate (ORR) which was pre-specified and was also shown to have a manageable safety profile during the trial.

The ORR was shown to be of 59.2% across all patient groups treated with copanlisib. It included 12% of the patient group who recorded complete response (CR) rate, and a median duration of response (DOR) of over 98 weeks.

Image: Building at the Pharma research center in Wuppertal, Germany. Photo: courtesy of Bayer AG.