Posted from: Monday, October 09, 2017 - 06:13 PM - Present

Aliqopa Approved for Follicular Lymphoma

September 14, 2017 – The U.S. FDA has approved Aliqopa™ (copanlisib), manufactured by Bayer, for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. A phosphatidylinositol-3-kinase (PI3K) inhibitor, Aliqopa works by blocking several enzymes responsible for promoting cell growth.

More than 72,000 patients in the United States are diagnosed with some form of non-Hodgkin lymphoma (NHL) each year; the disease is expected to prove fatal for 20,140 patients in 2017. Follicular lymphoma is the most common subtype of NHL, accounting for 22% of cases. Patients with the disease who have relapsed after prior therapies have limited treatment options.

Recommended dosing for Aliqopa is 60mg administered as an hour-long intravenous infusion on days 1, 8, and 15 of a 28-day treatment cycle. The drug will only be available through hospitals and clinics.

Bayer received accelerated approval for Aliqopa based on the results of a single-arm Phase II trial in which 59% of patients had a complete or partial response to the drug for a median of 12.2 months. It must pass a confirmatory trial demonstrating clinical benefit in order to maintain its approval.

Aliqopa has already been launched.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

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*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Friday, November 15, 2019 - 10:41 AM.