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FDA approves Alecensa, a new oral therapy to treat ALK-positive non-small cell lung cancer

The FDA ( U.S. Food and Drug Administration ) has approved Alecensa ( Alectinib ) 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 Xalkori ( Crizotinib ).

Lung cancer is 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 ).
An ALK ( anaplastic lymphoma kinase ) gene mutation can occur in several different types of cancer cells, including lung cancer cells.
ALK gene mutations are present in about 5% of patients 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.

Alecensa is an oral medication that blocks the activity of the ALK protein, which may prevent NSCLC cells from growing and spreading.

The safety and efficacy of 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 Xalkori.
Study participants received Alecensa twice daily to measure the drug’s effect on their lung cancer tumors.
In the first study, 38% 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% of participants experienced a partial shrinkage of their NSCLC tumors, lasting for an average of 11.2 months.
The trials also examined 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 Alecensa are fatigue, constipation, swelling ( edema ) and muscle pain ( myalgia ). Alecensa may cause serious side effects, including liver problems, severe or life-threatening inflammation of the lungs, very slow heartbeats and severe muscle problems.
Treatment with Alecensa may cause sunburn when patients are exposed to sunlight.

Alecensa was approved using the accelerated approval regulatory pathway, which allows the FDA to approve products for serious or life-threatening diseases based on evidence that the product has an effect on an outcome that is reasonably likely to predict clinical benefit.
In the case of Alecensa, the tumor response to treatment, along with the duration of response, provided this evidence.
Under the accelerated approval requirements, a confirmatory study is required to verify and describe the clinical benefit of Alecensa. ( Xagena )

Source: FDA, 2015