Monday, December 14, 2015

FDA approves new drug for sub-type of non-small cell lung cancer

CANCER DIGEST – Dec. 14, 2015 – The U.S. Food and Drug Administration approved Alecensa (alectinib) to treat people with specific form of non-small cell lung cancer.

The Dec. 11 approval was for non-small cell lung tumors that have a mutation in the anaplastic lymphoma kinase (ALK) gene, which is present in several types of cancer in addition to about 5 percent of non-small cell lung cancers. The approval is for treatment in patients whose disease has worsened after treatment with a drug called Xalkori (crizotinib), or who could not tolerate it.

In ALK-positive NSCLC, the cancer tends to spread to the brain, where few treatment options are available. Alecensa is an oral medication that blocks the activity of the ALK protein, which may prevent NSCLC cells from growing and spreading.

“Today’s 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, M.D., 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 have spread to the brain, which is an important effect for clinicians to understand.” 

The safety and effectiveness of Alecensa were shown in two single-arm clinical trials of patients with metastatic ALK-positive NSCLC whose disease was no longer controlled by treatment with Xalkori. In the first study participants received Alecensa twice daily to measure the drug’s effect on their lung cancer tumors. In that 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 Alecensa’s effect on individuals’ brain metastases. 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).

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