Algeta's Alpharadin Receives Fast Track Designation from FDA for Prostate Cancer Treatment

Strategic Insights -

Algeta ASA, a company focused on developing novel targeted cancer therapeutics, announced that its lead product, Alpharadin (radium-223 chloride), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of castration-resistant (hormone refractory) prostate cancer in patients with bone metastases. The company's President and CEO, Andrew Kay, attributed this achievement to the positive results of the pivotal phase III study, ALSYMPCA, which met its primary endpoint by significantly improving overall survival. This designation represents an important step towards Alpharadin's filing, which is expected to be submitted to the FDA in the second half of 2012.

Key Takeaways:

  • Alpharadin, a first-in-class, highly targeted alpha-pharmaceutical, has shown significant promise in treating bone metastases in patients with advanced cancer.
  • The ALSYMPCA trial, a global phase III clinical study, demonstrated that Alpharadin improved overall survival by 22.2% compared to a placebo (hazard ratio = 0.699, p-value = 0.0022) with a median overall survival of 14.0 months.
  • The trial was stopped early based on the positive results, and patients on the placebo arm were offered treatment with Alpharadin, which did not show any new or unexpected changes in its safety profile.
  • Algeta and Bayer Pharma AG have an agreement for the development and commercialization of Alpharadin, with Bayer retaining global rights and Algeta retaining an option for up to 50/50 co-promotion and profit-sharing in the United States.
  • The Fast Track designation allows for early and frequent communication between the FDA and the company to facilitate the development and review process.
  • Alpharadin is also being investigated in phase II clinical trials as a potential treatment for bone metastases in endocrine-refractory breast cancer patients and in combination with docetaxel chemotherapy in patients with castration-resistant prostate cancer.

Statistics:

  • Overall survival result: 14.0 months for Alpharadin and 11.2 months for placebo (hazard ratio = 0.699, p-value = 0.0022).
  • Patients with bone metastases from advanced cancer experience a dramatic decline in health and quality of life, ultimately leading to death.
  • 90% of prostate cancer patients, 60% of breast cancer patients, and 40% of lung cancer patients develop bone metastases during the late stages of their disease.

Sources:

  • "Algeta ASA: Algeta's Alpharadin Receives Fast Track Designation from FDA for Prostate Cancer Treatment" (August 23, 2011).
  • "Algeta ASA: Algeta and Bayer Announce Positive Results for Phase III ALSYMPCA Trial of Alpharadin in CRPC" (June 2011).
  • "Algeta ASA: Algeta and Bayer Announce Agreement for Development and Commercialization of Alpharadin" (September 2009).
  • "Algeta ASA: About Algeta" (algeta.com/about).
  • "U.S. Food and Drug Administration: Fast Track" (fdasecurityinfo.com/fda_fasttrack).