FDA Grants Lung Cancer Drug Priority Review

Alectinib is an oral anaplastic lymphoma kinase inhibitor for locally advanced or metastatic non-small cell lung cancer.

The FDA announced this week that it accepted Genentech’s New Drug Application (NDA) and granted Priority Review to Genentech’s alectinib, an oral investigational anaplastic lymphoma kinase (ALK) inhibitor.

The drug treats patients with ALK-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on, or are intolerant to, critzotinib.

“Alectinib was granted Priority Review by the FDA based on results from two studies showing the medicine shrank tumors in people with ALK-positive NSCLC that progressed on crizotinib,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “There is a need for new treatment option in this patient population, especially because the disease often spreads to the brain at progression.”

Alectinib was granted Breakthrough Therapy Designation by the FDA in 2013 for people with ALK-positive NSCLC whose disease progressed on crizotinib.

The NDA for alectinib includes findings from a pair of phase 2 studies. Results from the studies show that alectinib successfully reduced tumors in 47.8% of people treated with the therapy. The FDA will make a decision on approval for alectinib by March 4, 2016.

A phase 3 study is also ongoing to compare alectinib to crizotinib as an initial treatment for people with advanced NSCLC who had tumors characterized as ALK-positive by a companion immunohistochemistry test developed by Roche Diagnostics.

Lung cancer is a serious disease and a major area of focus for Genentech. According to the American Cancer Society, more than 221,000 people will be diagnosed with lung cancer in the United States in 2015. NSCLC specific lung cancer accounts for 85% of all lung cancers. With 60% of lung cancer diagnoses in the United States made when the disease is in the advanced stages, it is of the utmost importance to develop drugs such as alectinib that are fast-acting and effective in the treatment of NSCLC tumors.