Bayer and Onyx Announce Availability of Sorafenib for Advanced Renal Cell Carcinoma

Strategic Insights -

Sorafenib, a medication developed by Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc., is now available to individuals with advanced renal cell carcinoma (RCC) through a treatment protocol announced by the two companies. This program, known as the Advanced Renal Cell Carcinoma Sorafenib (ARCCS) study, has been reviewed by the U.S. Food and Drug Administration (FDA) and is currently being implemented at clinical sites across the United States. Patients with advanced kidney cancer who have not previously received Sorafenib are eligible to participate in the study.

Key Takeaways:

  • The ARCCS study is an open-label treatment protocol for individuals with advanced kidney cancer that involves the use of Sorafenib, a medication developed by Bayer and Onyx.
  • To be eligible, patients must have advanced kidney cancer and not have been previously treated with Sorafenib.
  • The study has been reviewed by the FDA and is being implemented at clinical sites throughout the United States.
  • Susan Kelley, MD, vice president of Oncology at Bayer Pharmaceuticals Corporation, stated that the companies have been encouraged by the results of their clinical trials to date and look forward to initiating this protocol for individuals with advanced kidney cancer.
  • Bernard Escudier, Head of Immunotherapy and Innovative Therapy Unit at the Gustave-Roussy Institute, reported that disease progression was significantly delayed in patients receiving Sorafenib, with a median progression-free survival (PFS) of 24 weeks compared to 12 weeks for patients receiving placebo.
  • Bayer and Onyx are currently preparing a New Drug Application (NDA) for possible approval in this indication by the FDA in the United States.
  • Discussions are underway with regulatory agencies about registration in other territories.
  • Bill Bro, president of the Kidney Cancer Association, welcomed the announcement, stating that sorafenib results are encouraging for individuals suffering from advanced kidney cancer.

Statistics:

  • Median progression-free survival (PFS) for patients receiving Sorafenib was 24 weeks (167 days).
  • Median PFS for patients receiving placebo was 12 weeks (84 days).
  • The largest randomized, controlled trial in advanced RCC is currently being conducted to evaluate the efficacy of Sorafenib.
  • Discussions about similar programs in other territories are anticipated to begin soon.

Sources:

  • Bayer Pharmaceuticals Corporation
  • Onyx Pharmaceuticals, Inc.
  • Susan Kelley, MD, vice president of Oncology, Bayer Pharmaceuticals Corporation
  • Bernard Escudier, Head of Immunotherapy and Innovative Therapy Unit, Gustave-Roussy Institute
  • Bill Bro, president, Kidney Cancer Association
  • Health & Medicine Week editors
  • NewsRx.com