Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
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.
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.