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Roche Receives Negative Opinion on Tarceva Approval for Pancreatic Cancer

Strategic Insights

— 2 min read

Roche, a leading global healthcare company, received a negative opinion from the European Committee for Medicinal Products for Human Use regarding the approval of Tarceva (erlotinib) in combination with gemcitabine chemotherapy as first-line, once-daily, oral therapy for locally advanced, inoperable or metastatic pancreatic cancer. This decision is a setback for patients with pancreatic cancer, a devastating disease with limited treatment options. Despite this setback, Tarceva has shown significant promise in clinical trials, particularly in the treatment of non-small cell lung cancer (NSCLC). Tarceva is a small molecule designed to target the human epidermal growth factor receptor 1 pathway, a critical factor in cell growth in NSCLC and other solid tumors.

Key Takeaways:

  • Tarceva, in combination with gemcitabine chemotherapy, has shown a statistically significant improvement in overall survival in a Phase III clinical trial for patients with advanced pancreatic cancer.
  • Roche is evaluating its options, including a possible request for re-examination of the decision, after receiving a negative opinion from the European Committee for Medicinal Products for Human Use.
  • Tarceva is approved in over 50 countries worldwide for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of at least one prior chemotherapy regimen.
  • Results from two earlier large, randomized, placebo-controlled Phase III clinical trials in first-line advanced NSCLC patients showed no clinical benefit with concurrent administration of Tarceva with doublet platinum-based chemotherapy.
  • Tarceva is the only HER1/EGFR-targeted therapy proven to significantly prolong survival in second-line NSCLC as a single agent.
  • The U.S. Food and Drug Administration approved the use of Tarceva in combination with gemcitabine chemotherapy for the treatment of locally advanced unresectable or metastatic pancreatic cancer in November 2005.

Statistics:

  • Tarceva has been shown to prolong survival in second-line NSCLC patients by a statistically significant margin.
  • In a Phase III clinical trial, the Tarceva-gemcitabine combination showed a statistically significant improvement in overall survival for patients with advanced pancreatic cancer.
  • Tarceva has been approved in over 50 countries worldwide for the treatment of NSCLC.
  • Results from two earlier Phase III clinical trials showed no clinical benefit with concurrent administration of Tarceva with doublet platinum-based chemotherapy in first-line advanced NSCLC patients.
  • The U.S. FDA approved the use of Tarceva in combination with gemcitabine chemotherapy for the treatment of locally advanced unresectable or metastatic pancreatic cancer in November 2005.

Sources:

  • Health & Medicine Week
  • NewsRx.com
  • OSI Pharmaceuticals, Inc. (OSIP) press release
  • European Committee for Medicinal Products for Human Use
  • U.S. Food and Drug Administration (FDA)

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