(RxWiki News) A lung cancer drug has received regular approval from the US Food and Drug Administration (FDA).
The medication is called Alecensa (alectinib). The FDA approved it to treat anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) that has been confirmed by an FDA-sanctioned test.
Alectinib was granted accelerated approval in late 2015, but the FDA has now approved Alecensa after a larger trial has suggested that the medication is safe and effective for patients with ALK-positive non-small cell lung cancer. In fact, patients who took Alecensa survived more than twice as long as those who received a different non-small cell lung cancer drug.
Among patients who took this oral medication, low red blood cell counts, muscle pain, swelling, constipation and fatigue were relatively common side effects. Rare but serious adverse reactions included kidney impairment, signs of too much red blood cell breakdown and indicators of liver damage.
Talk to your health care provider about the potential side effects of any new cancer medication you're prescribed.
The FDA granted approval of Alecensa to Hoffmann-La Roche and Genentech.