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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.