Bayer AG (BAYN.XE) says it has received regulatory approval in the U.S. for its cancer drug Copanlisib.
The German pharmaceutical company said late Thursday that the U.S. Food and Drug Administration has approved Copanlisib under the brand name Aliqopa. The intravenous cancer drug has been approved for the treatment of adult patients with relapsed follicular lymphoma who have previously been treated with at least two systemic therapies.
The FDA granted approval based on the overall response rate of 104 adult patients in the Phase II Chronos-1 study, the company said. The FDA had granted Bayer the primary screening test in May.
Bayer said that continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
"We are pleased that the FDA has recognized the promising results of the Chronos-1 trial and look forward to offering this new treatment option to patients with lymphoma, who currently have a high unmet need for effective therapies," said Robert LaCaze, executive vice president and head of the oncology strategic business unit at Bayer.
Write to Marc Navarro Gonzalez at firstname.lastname@example.org
(END) Dow Jones Newswires
September 15, 2017 02:48 ET (06:48 GMT)