FDA Approves Genentech’s ALECENSA as Oral Therapy for Advanced ALK-positive Non-small Cell Lung Cancer

FDA Approves Genentech’s ALECENSA as Oral Therapy for Advanced ALK-positive Non-small Cell Lung Cancer

ALECENSA (alectinib), a therapy commercialized by Genentech, was approved by U.S. Food and Drug Administration for the treatment of patients with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) previously treated with Xalkori (crizotinib) that worsened clinically or were intolerant to the treatment. Alecensa is an oral medication that blocks the activity of the anaplastic lymphoma kinase (ALK) protein, which can inhibit proliferation and metastasis of NSCLC cells.

Lung cancer is the most frequent type of cancer and leading cause of death in the United States. In 2015, it was estimated that 221,200 new cases were diagnosed and 158,040 deaths occurred in the US as a result of the disease, according to the National Cancer Institute. Several different types of cancer, such as lung cancer, have a mutation in the anaplastic lymphoma kinase (ALK) gene. In non-small cell lung cancer, 5% of patients have these mutations. In ALK-positive NSCLC metastatic patients, the tumor frequently spreads to the brain.

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA, said that ALECENSA ‘sapproval by FDA provided a novel alternative treatment to patients that no longer respond to Xalkoni therapy.

The effectiveness of ALECENSA was shown in patients with metastatic ALK-positive NSCLC that no longer responded to treatment with Xalkori by measuring two types of response to therapy, i.e. response rate and duration of response. The enrolled participants were treated twice a day with ALECENSA to evaluate the effect of the drug on lung tumors. In the first and second study, 38 and 44% of participants showed a partial reduction of their NSCLC tumors for 7.5 and 11.2 months, respectively. Both studies also addressed the effect of the drug in participants with brain metastases, a frequent event observed in this type of cancer. Among these patients, 61% showed a complete or partial reduction in their brain metastases, a result observed over the course of 9.1 months. Currently, there is a study evaluating the effects of ALECENSA for longer period of time.

ALECENSA was granted an application as a breakthrough therapy, orphan drug designations, and priority review status by FDA.

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