Roche Wins FDA Approval for Test to Target Lung Cancer

Roche Holding AG, the world’s biggest maker of cancer drugs, won U.S. approval to sell a gene mutation test that can help doctors pinpoint patients’ likelihood to respond to a popular treatment for lung cancer.

The diagnostic detects epidermal growth factor receptor gene mutations, and can be used as a companion with Roche and Astellas Pharma Inc.’s drug Tarceva as a first-line cancer treatment. The Food and Drug Administration approval includes the test and the expanded use of Tarceva as an initial treatment for patients with non-small cell lung cancer that has spread in the body and have certain EGFR mutations.

Non-small cell lung cancer accounts for 85 percent of lung cancers, the FDA said. About 228,190 people will be diagnosed with lung cancer in the U.S. this year and 159,480 patients will die of the disease, according to the National Cancer Institute. Tarceva generated $1.4 billion in sales for Basel, Switzerland-based Roche last year as a second- and third-line therapy and as a maintenance treatment for the disease.

“Companion diagnostics play an important role in determining which therapies are the safest and most effective for a particular patient,” Alberto Gutierrez, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said yesterday in a statement announcing the approval.

Hal Barron, chief medical officer for Roche, said 10 percent to 30 percent of people worldwide with lung cancer have tumors that test positive for certain EGFR mutations.

Similar Combination

Roche rose 0.9 percent to 246 Swiss francs at 9:42 a.m. in Zurich. The stock has gained 34 percent this year. Astellas gained 4.3 percent, the most in almost six weeks, to close at 6,010 yen in Tokyo, where the company is based. It’s the stock’s highest price in 13 years.

Boehringer Ingelheim GmbH and Qiagen NV are waiting on FDA clearance, expected in July, for a similar drug-and-diagnostic combination. The companies are seeking approval of Boehringer’s experimental drug afatinib to treat advanced or metastatic non-small cell lung cancer in people who have an EGFR gene mutation and Qiagen’s therascreen EGFR diagnostic test.

Another gene mutation test received attention yesterday when actress Angelina Jolie revealed she had a double mastectomy after learning she had an inherited mutation of the BRCA1 gene. Myriad Genetics Inc., is the sole U.S. provider of BRCA1 and BRCA2 tests. The company’s screens aren’t FDA approved.

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