FDA Roundup: New Options for Lung Cancer, von Willebrand Disease

Alecensa - ALK-positive Non-Small Cell Lung Cancer

The FDA has approved Alecensa (alectinib) for the treatment of patients with advanced ALK-politive non-small cell lung cancer who did not see positive results with crizotinib.
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The drug works by preventing the growth and spread of cancer cells by blocking the ALK protein.

The safety and efficacy of Alecensa were evaluated in 2 single-arm clinical trials of patients who received Alecensa twice daily. In the first study, 38% of participants saw shrinkage in their tumors, which lasted 7.5 months. In the second study, 44% saw shrinkage, lasting for 11.2 months.

The most common side effects recorded were fatigue, constipation, swelling and muscle pain.  More serious side effects include liver problems, inflammation of the lungs, slow heartbeat, and muscle problems.

Vistogard – Overdose of Chemotherapy

The FDA has approved Vistogard (uridine triacetate) for the emergency treatment of an overdose of cancer-treating fluorouracil or capecitabine.

The drug, taken orally, blocks cell damage and dealth caused by an overdose of the chemotherapy.

The safety and efficacy of Vistogard were evaluated in 135 cancer patients in 2 trials. Of those treated with Vistogard, 97% were still alive after 30 days and 33% resumed chemotherapy in less than 30 days.

The most common side effects were diarrhea, vomiting, and nausea.

Vonvendi – von Willebrand Disease

The FDA has approved Vonvendi, von Willebrand factor (recombinant) for the treatment of bleeding episodes in patients with von Willebrand disease.

The safety and efficacy of Vonvendi were evaluated in 2 trials of 69 participants.

Overall, Vonvendi effectively controlled bleeding episodes in a variety of body sites. No safety concerns were identified.

—Michael Potts

References:

FDA. FDA approves new oral therapy to treat ALK-positive lung cancer [press release]. December 11, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476926.htm.

FDA. FDA approves first emergency treatment for overdose of certain types of chemotherapy [press release]. December 11, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476919.htm.

FDA. FDA approves first recombinant von Willebrand factor to treat bleeding episodes [press release]. December 8, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm476065.htm.