5 things to know about the new lung cancer drug

December 15, 2015

FDA granted accelerated approval to Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

FDA granted accelerated approval to Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

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“[The] approval provides a new therapy for a group of patients who would have few treatment options once their disease no longer responds to treatment with Xalkori,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to the primary effect on tumors in the lung, Alecensa clinical trials provide evidence of an effect on tumors that had spread to the brain, which is an important effect for clinicians to understand.” 

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Here are the most important facts to know about Alecensa:

  • Manufactured by Genentech, the drug is expected to be available by the end of December.

  • The monthly cost of Alecensa will be approximately $12,500. “We have a copay card that can help eligible patients with private insurance so they will pay $25 per copay. This is one of many services to help people access our medicines,” a Genentech spokesperson told FormularyWatch. For those who qualify, Genentech plans to offer patient assistance programs for people taking Alecensa through Genentech Access Solutions. Doctors can contact Genentech Access Solutions at (888) 249-4918.

  • In studies, Alecensa shrank tumors in up to 44% of people with ALK-positive NSCLC who progressed on crizotinib. In a subset of people with tumors that spread to the brain or other parts of the central nervous system (CNS), Alecensa shrank CNS tumors in about 60% of people.

  • Alecensa is also being studied for use as an initial (first-line) treatment for people with advanced ALK-positive NSCLC. The global, randomized phase 3 study compares Alecensa to crizotinib as an initial treatment for people with advanced NSCLC whose tumors were characterized as ALK-positive by a companion VENTANA ALK (D5F3) CDx Assay immunohistochemistry (IHC) test developed by Roche Diagnostics.

  • Possible serious side effects of Alecensa include liver problems, lung problems, slow heartbeat, muscle pain, tenderness and weakness. The most common side effects of Alecensa include tiredness, constipation and swelling in the hands, feet, ankles and eyelids. 

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