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Accelerated Approval for New FL Treatment

FDA news release; 2017 Sep 14

The FDA has granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma (FL).

Indications: Aliqopa is a kinase inhibitor indicated for the treatment of adult patients with relapsed FL who have received at least 2 prior systemic therapies.

Dosage and administration: 60 mg administered as a 1-hour intravenous infusion on days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (3 weeks on and 1 week off).

Efficacy and safety: Approval is based on data from a single-arm trial showing that 6 in every 10 patients had a complete or partial response for a median of 12.2 months.

Side effects/risks: Most common adverse reactions are hyperglycemia, diarrhea, decreased general strength and energy, hypertension, leukopenia, neutropenia, nausea, lower respiratory tract infections, and thrombocytopenia.

Citation:

FDA approves new treatment for adults with relapsed follicular lymphoma [news release]. Silver Spring, MD: FDA. September 14, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576129.htm. Accessed September 18, 2017.

Aliqopa [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc. 2017. http://labeling.bayerhealthcare.com/html/products/pi/Aliqopa_PI.pdf. Accessed September 18, 2017.