FDA approval for Boehringer means fast competition to Roche's targeted Tarceva

In May, the FDA approved Roche's ($RHHBY) diagnostic test for its cancer drug Tarceva, saying it was the first approved to detect EGFR mutations. That led the agency to give a new first-line approval to Tarceva, so broadening the earnings power of the blockbuster. But that distinction has held for only two months. The FDA today approved a new targeted lung cancer drug from Boehringer Ingelheim and its companion test that can detect the same mutation.

The FDA in a statement today said it approved Boehringer's Gilotrif (afatinib) for people with late-stage, non-small cell lung cancer (NSCLC), along with a Qiagen ($QGEN) diagnostic to test for the gene mutation that makes patients respond more effectively. It pointed out that lung cancer is the leading cause of cancer-related death among adults in the U.S. and that about 85% of lung cancers are NSCLC. About 10% to 30% are believed to display the mutation.

The FDA said that in a study, patients treated with Gilotrif had a delay in tumor growth that was 4.2 months longer than those receiving chemotherapy, although there was no statistically significant difference in overall survival. The company in June said that patients taking the drug lived for almost a year before their tumors started to grow again, compared with less than half a year for those on standard chemotherapy, according to Bloomberg

This targeted kind of treatment is desirable because it can help doctors know which patients will respond to which treatments, saving payers money and patients unnecessary treatments. The drugs, however, often come with high prices. Roche has put a lot of effort and money into developing these kinds of drugs, and with good results. Tarceva brought in $1.4 billion in sales last year, Bloomberg said.

Tarceva was not the first targeted lung-cancer drug, however. Pfizer ($PFE) has Xalkori, which is designed for patients with certain mutations in a different gene, ALK. That drug was approved in 2011, along with a companion diagnostic developed with Abbott Laboratories ($ABT).

- here's the FDA announcement
- read the Bloomberg story
- here's FierceMedicalDevices' take on Qiagen's test

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