Alectinib (Alecensa) approved for treatment of patients with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC)

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December 12, 2015 – The American Food and Drug Administration today approved Alectinib (Alecensa) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Crizotinib (Xalkori).

The ALK gene (coding for anaplastic lymphoma kinase protein, also known as ALK tyrosine kinase inhibitor, or CD248) can be oncogenic in three ways, namely a) by forming a fusion gene with any of several other genes, b) by gaining additional gene copies or , c) with mutations of the actual DNA code for the gene itself. An ALK  gene mutation can occur in several different types of cancer cells, including lung cancer cells. ALK gene mutations are present in about 5 percent of patients

Alectinib chemical structure

Alectinib chemical structure

with NSCLC. In metastatic cancer, the disease spreads to new parts of the body. In ALK-positive NSCLC metastatic patients, the brain is a common place for the disease to spread. Alectinib (Alecensa) is an oral medication that blocks the activity of the ALK protein, which may prevent NSCLC cells from growing and spreading. In addition to the primary effect on tumors in the lung, Alectinib (Alecensa) clinical trials provide evidence of an effect on tumors that had spread to the brain, which is an important aspect of this medicine for clinicians to note.

The safety and efficacy of Alectinib (Alecensa) were studied in two single-arm clinical trials of patients with metastatic ALK-positive NSCLC whose disease was no longer controlled by treatment with Crizotinib (Xalkori). Study participants received Alectinib (Alecensa) twice daily to measure the drug’s effect on their lung cancer tumors. In the first study, 38 percent of participants experienced a partial shrinkage of their NSCLC tumors, an effect that lasted for an average of 7.5 months. In the second study, 44 percent of participants experienced a partial shrinkage of their NSCLC tumors, lasting for an average of 11.2 months. The trials also examined Alectinib (Alecensa)’s effect on individuals’ brain metastases, a common occurrence in this population. Sixty-one percent of participants in the two trials who had measurable brain metastases experienced a complete or partial reduction in their brain tumors, lasting an average of 9.1 months.

The most common side effects of Alectinib (Alecensa) are fatigue, constipation, swelling (edema) and muscle pain (myalgia). Alectinib (Alecensa) may also cause more serious side effects, including liver problems, severe or life-threatening inflammation of the lungs, very slow heartbeats and severe muscle problems. Treatment with Alectinib (Alecensa) may cause sunburn when patients are exposed to sunlight.

According to Richard Pazdur, M.D., Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research provides the approval of Alectinib (Alecensa) provides an important new therapy option for a group of patients who would have few treatment choices once their disease no longer responds to treatment with Crizotinib (Xalkori). Overall, lung cancer remains the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute (NCI).



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About the Author
Joseph Gut - thasso Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

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