Roche Requests Re-Examination of Tarceva for Pancreatic Cancer Treatment

Strategic Insights -

Tarceva, a breakthrough cancer medicine, has shown a significant survival benefit for patients with pancreatic cancer, prompting Roche to request a re-examination of the data supporting its filing for European approval. Pancreatic cancer is a highly aggressive form of cancer, killing more people within the first year of diagnosis than any other cancer. The disease has limited treatment options, and Tarceva's effectiveness has been demonstrated in clinical trials. Roche's President, Eduard Holdener, stated that patients with pancreatic cancer need new treatment options like Tarceva, which has been proven to significantly increase survival.

Key Takeaways:

  • Roche has requested a re-examination of the data supporting the filing of Tarceva for the treatment of pancreatic cancer after a negative opinion from the European Committee for Medicinal Products for Human Use (CHMP).
  • Tarceva, in combination with gemcitabine chemotherapy, has shown a significant survival benefit in patients with advanced pancreatic cancer, with a 22% increase in survival compared to gemcitabine alone.
  • The PA3 study, conducted by the National Cancer Institute of Canada Clinical Trials Group, demonstrated that Tarceva plus gemcitabine resulted in significantly longer survival, progression-free survival, and tolerability in patients with advanced pancreatic cancer.
  • Pancreatic cancer is a rapidly fatal disease, with limited treatment options, and is the tenth most frequently occurring cancer in Europe.
  • Tarceva is a small molecule that targets the human epidermal growth factor receptor (HER1) pathway, and has been approved for the treatment of non-small cell lung cancer (NSCLC) in the US and EU.
  • Roche is committed to realizing the potential of Tarceva in treating pancreatic cancer through its extensive clinical trial program.

Statistics:

  • Pancreatic cancer kills more people within the first year of diagnosis than any other cancer.
  • 24% of patients receiving Tarceva plus gemcitabine were alive after one year, compared to 19% on gemcitabine alone.
  • The PA3 study involved 569 patients, with Tarceva plus gemcitabine demonstrating a 22% increase in survival.
  • Tarceva has been approved for the first-line treatment of locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine chemotherapy.

Sources:

  • Moore MJ, Goldstein D, Hamm J, et al. Erlotinib plus gemcitabine compared to gemcitabine alone in patients with advanced pancreatic cancer. A Phase III trial of the National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG). (Abstract #1, ASCO 2005)
  • Steward, B W and Kleihues, P. 2003. World Cancer Report. World Health Organisation and the International Agency for Research on Cancer, IARC Press/Lyon, p248
  • De Braud F, Cascinu S, Gatta G. 2004, May. Cancer of Pancreas. Critical reviews in oncology/hematology, 50(2):147-55