Tarceva - $564.2 million

Image removed.Tarceva

Company: Genentech
2011 sales: $564.2 million
Developers: OSI Pharmaceuticals, Genentech and Roche
FDA approvals: Non-small cell lung cancer, 2004; pancreatic cancer, 2005; NSCLC maintenance therapy, 2010

Tarceva is another drug that targets the epidermal growth factor receptor pathway, but until recently, its regulatory approvals weren't limited to EGFR-positive cancers. That changed in September, when Tarceva won European regulators' blessing as a first-line treatment for NSCLC patients testing positive for EGFR-activating mutations. It was already European Medicines Agency approved for second-line treatment in lung cancer whatever the patient's EGFR status.

Now, the company is working with the FDA on submitting Tarceva for U.S. approval in the same targeted population, in combination with a diagnostic test for identifying patients with the appropriate EGFR status. And its EGFR-specific approval in U.K. got an affirmation last week, when the National Institute for Health and Clinical Excellence recommended first-line Tarceva treatment in EGFR-positive lung cancers. NICE previously had declined to approve that use, but Roche handed in some new information and analyses that saved the day.

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Tarceva - $564.2 million