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Roche Submits Marketing Authorization Application for Tarceva in Europe, Expanding Treatment Options for Advanced NSCLC Patients

Strategic Insights

— 1 min read

Roche, a leading biotechnology company, has submitted a marketing authorization application to the European Medicines Agency (EMEA) for Tarceva (erlotinib) as a first-line maintenance therapy for patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy. This development is part of Roche's efforts to bring innovative treatments to patients with cancer, building on the company's expertise in cancer research and development.

Key Takeaways:

  • Tarceva is a targeted therapy designed to inhibit the EGFR pathway, critical to cell growth in NSCLC and pancreatic cancers.
  • The approval process for Tarceva in the EU is based on the SATURN trial, a pivotal Phase III placebo-controlled, randomized, double-blind study.
  • In the SATURN study, Tarceva significantly extended the time patients with advanced NSCLC lived without their cancer getting worse (progression-free survival or PFS) when given immediately following initial treatment with platinum-based chemotherapy.
  • The most common side effects associated with Tarceva in the non-small cell lung cancer clinical study were rash, diarrhea, fatigue, nausea, loss of appetite, and vomiting.
  • Lung cancer is the single largest cause of cancer death among men and women in the U.S., with nearly 162,000 Americans dying from the disease in 2008.
  • NSCLC is the most common type of lung cancer, with the majority of patients diagnosed with advanced stage disease that cannot be surgically removed or has spread to other parts of the body.
  • Tarceva is also approved in combination with gemcitabine for the treatment of patients with locally advanced or metastatic pancreatic cancer.
  • OSI Pharmaceuticals and Genentech announced that the U.S. FDA has invalidated the standard-of-care regulation for treatment of NSCLC with platinum based chemotherapy.

Statistics:

  • 889 patients were enrolled in the SATURN study, which was conducted at approximately 160 sites worldwide.
  • The primary endpoint of the SATURN study was progression-free survival.
  • Secondary endpoints included overall survival, safety, and an evaluation of exploratory biomarkers.
  • In the SATURN study, the most common side effects associated with Tarceva were rash (54%), diarrhea (43%), fatigue (26%), nausea (25%), loss of appetite (22%), and vomiting (20%).
  • The majority of patients with advanced lung cancer survive less than one year.

Sources:

  • OSI Pharmaceuticals press release (www.osip.com)
  • Genentech press release (www.gene.com)
  • American Cancer Society (ACS) website (www.cancer.org)
  • European Medicines Agency (EMEA) website (www.ema.europa.eu)

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