Bayer Leads Drug Approval NewsBy
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Bayer.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, September 13, 2017 to Tuesday, September 19, 2017.
Bayer Receives FDA Approval for Lymphoma Drug
The US Food and Drug Administration (FDA) has approved Bayer’s Aliqopa (copanlisib), 60-mg vial for injection, as a new molecular entity for treating adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.
Copanlisib 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.
Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The drug will be available in the US market immediately.