Roche wins new targeted OK for Tarceva in EGFR-positive lung cancer

Roche's ($RHHBY) targeted-drug crusade marches on. Along with its partner, Astellas, the company won FDA approval for a new, first-line use for its lung cancer drug Tarceva in patients whose cancers test positive for specific mutations of the EGFR gene. Roche also got the nod for a diagnostic test to identify eligible patients.

EGFR mutations are found in 10% to 30% of patients with non-small cell lung cancer, Roche CMO Hal Barron, who also heads up Genentech Global Product Development, said in a statement. "People with this type of lung cancer now have the option to use a personalized medicine as their initial treatment," he said.

Roche's cobas EGFR Mutation Test is the first FDA-approved companion diagnostic that detects EGFR mutations in lung cancer, the agency said in its announcement of the approval. The agency cited research showing that EGFR-positive patients who received Tarceva lived for 10.4 months without their disease progressing, compared with 5.4 months for patients on standard two-drug chemo.

Previously, Tarceva had FDA approval for certain lung cancer patients, regardless of their EGFR status. It was only approved for use in later stages of treatment: to treat patients who've failed on at least one chemotherapy regimen and as a maintenance therapy for patients who've already used chemo. The new first-line indication applies to patients whose cancer has metastasized. European regulators gave their blessing to the first-line Tarceva use in EGFR patients in September 2011.

This pairing of a drug with a diagnostic test is Roche's key strategy for growth. CEO Severin Schwan spent part of his career running the company's diagnostics business, and he's sold on the promise of targeting particular cancers with particular drugs. Underscoring that commitment, Schwan appointed his former diagnostics chief Daniel O'Day to run Roche's pharma division last year after Pascal Soriot left to join AstraZeneca ($AZN).

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

- see the Genentech press release
- read the FDA statement

Special Reports: Tarceva - Top 10 best-selling cancer drugs | Severin Schwan - The 25 most influential people in biopharma today - 2012 | Daniel O'Day - Roche - The 25 most influential people in biopharma today - 2013

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