Genentech’s Alecensa Wins FDA Approval

The FDA has granted approval to Genentech’s Alecensa for metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer in patients whose disease has worsened after taking Pfizer’s Xalkori, or who could not tolerate the treatment.

An oral medication, Alecensa (alectinib) blocks the activity of the ALK protein, which may prevent NSCLC cells from growing and spreading. Patients with the ALK gene mutation in lung cancer cells often experience metastasis of the brain.

In a one clinical trial, 38 percent of patients with metastatic ALK-positive NSCLC whose disease was no longer controlled by treatment with Xalkori (crizotinib) experienced a partial shrinkage of their tumors, which lasted for an average of 7.5 months. A second study found 44 percent of patients experienced the same effect, lasting an average of 11.2 months.

Genentech spokesman Andrew Villani says the monthly cost of Alecensa is approximately $12,500, and the company is offering a co-pay card to help eligible patients with private insurance pay $25 per co-pay.