FDA OKs Follicular Lymphoma Treatment


Further clinical trials are required to confirm Aliqopa’s clinical benefit, and the sponsor is conducting these studies.

Officials with the FDA have granted accelerated approval to copanlisib (Aliqopa, Bayer) to treat adults with relapsed follicular lymphoma who have received at least 2 prior treatments systemic therapies.

The approval of Aliqopa, which is a kinase inhibitor that works by blocking several enzymes that promote cell growth, was based on data from the CHRONOS-1 single-arm trial that included 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed following at least 2 prior treatments. In the trial, 59% of patients had a complete or partial response for a median 12.2 months.

Aliqopa received an accelerated approval, which allows the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients. Further clinical trials are required to confirm Aliqopa’s clinical benefit, and the sponsor is conducting these studies.

Common adverse effects of the treatment include hyperglycemia, diarrhea, decreased general strength and energy, hypertension, low levels of certain white blood cells, and thrombocytopenia.

“For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the agency’s Center for Drug Evaluation and Research, said in a statement. “Options are limited for these patients, and today’s approval provides an additional choice for treatment, filling an unmet need for them.”

Pharmacists have an important role to play in educating patients about treatment options for cancer.

In the clip below, Brandon Shank, PharmD, MPH, BCOP, clinical pharmacy specialist, explains his role as a pharmacist to enhance care for patients with cancer. He works closely with patients during transitions of care to teach them proper administration of medications, such as chemotherapy. Moreover, Dr. Shank speaks of the importance of close follow-up to determine any adverse effects or problems with insurance coverage.


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

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