Boehringer Ingelheim GmbH, the German family owned drugmaker, won U.S. approval for a lung cancer therapy to be used with a Qiagen NV gene test that pinpoints patients who will best respond to the medication.
The Food and Drug Administration in a statement today said it cleared the drug afatinib for people with advanced or spreading non-small cell lung cancer along with a Qiagen diagnostic to test for the gene mutation that makes patients respond more effectively. Qiagen’s therascreen diagnostic tests for a mutation in the epidermal growth factor receptor, or EGFR.
Lung cancer is the leading cause of cancer death in the U.S., according to the American Cancer Society. Almost 160,000 Americans will die from the disease this year. As many as 90 percent of patients have the non-small cell type, the Atlanta-based advocacy group said.
Roche Holding AG gained approval in May for a diagnostic to check for EGFR mutations that accompanies the lung cancer drug Tarceva from Roche and Astellas Pharma Inc.
Tarceva also was approved for wider use at the same time as an initial treatment for patients with the EGFR mutation. As a second- and third-line therapy and a maintenance treatment for the disease, the drug generated $1.4 billion in 2012 sales for Basel, Switzerland-based Roche, according to data compiled by Bloomberg. Ten percent to 30 percent of people worldwide with lung cancer have tumors that test positive for certain EGFR mutations, Roche said.
Patients taking Ingelheim, Germany-based Boehringer’s afatinib in a clinical trial lived for almost a year before their tumor started to grow again compared with less than half a year for those on standard chemotherapy, the company said in a June 1 statement.