US FDA expands use of Roche’s lung cancer drug; approves genetic test

The Food and Drug Administration has expanded the use of Roche subsidiary Genentech’s advanced lung cancer drug, Tarceva (erlotinib). Tarceva is now the first personalised medicine approved for patients with EGFR mutation-positive advanced non-small cell lung cancer in the United States.

As well as this new use, the FDA also approved the cobas EGFR Mutation Test, which is a companion diagnostic for Tarceva developed by Roche. This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10% of non-small cell lung cancers (NSCLC).

“Ten to 30 percent of people worldwide with lung cancer have tumors that test positive for certain EGFR mutations. People with this type of lung cancer now have the option to use a personalized medicine as their initial treatment to help them live longer without their disease worsening.”

Hal Barron, M.D., chief medical officer and head, Genentech Global Product Development.

Tarceva is already approved in the United States, irrespective of histology or biomarker status, for people with advanced-stage NSCLC whose cancer has not spread or grown after initial treatment with certain types of chemotherapy (maintenance treatment). The drug has also been approved for patients with advanced-stage NSCLC whose cancer has spread or grown after receiving at least one chemotherapy regimen (second- or third-line treatment).

Lung cancer is the leading cause of cancer-related death among men and women, with an estimated 228,190 new cases of lung cancer just this year. Approximately 85% of lung cancers are NSCLC, making it the most common type of lung cancer, according to the National Cancer Institute.



Related news:

FDA approves Roche diagnostic for gene mutation in lung cancer (Reuters)

Reference links:

FDA press release

Genentech press release

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