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Pharmaceutical industry

FDA Decision on Avastin Sparks Concerns from Susan G. Komen for the Cure

Strategic Insights

— 1 min read

Susan G. Komen for the Cure, a leading breast cancer advocacy organization, has expressed concerns over the potential impact on patients benefitting from the cancer drug Avastin, following a U.S. Food and Drug Administration (FDA) decision to begin the process of removing approval for the drug as a treatment for metastatic breast cancer. The FDA's decision gives drug manufacturer Genentech/Roche 15 days to file an appeal for a public hearing and a review process that could take several months. Komen for the Cure's president, Elizabeth Thompson, emphasized the importance of continued access to Avastin for women who are using it and for whom it is working.

Key Takeaways:

  • The FDA has begun the process of removing approval for Avastin as a treatment for metastatic breast cancer, citing studies that indicate the drug did not affect overall survival and had significant side effects.
  • Genentech/Roche has 15 days to file an appeal for a public hearing and review, which could take several months.
  • Komen for the Cure is concerned about the potential impact on women who are benefiting from Avastin and is urging the drug's manufacturer to maintain patient access programs and consider an expanded access program.
  • The organization is also urging continued research on a biomarker for Avastin to determine which women will benefit from the drug.
  • Komen for the Cure supports the development of new medications for the treatment of metastatic breast cancer and calls on stakeholders to invest in biomarker development and new drug treatments.

Statistics:

  • Over $1.5 billion has been invested by Susan G. Komen for the Cure in the fight against breast cancer, making it the largest source of nonprofit funds dedicated to the cause worldwide.
  • Avastin is a leading treatment for metastatic breast cancer, with many breast cancer patients relying on it for treatment.
  • Studies have shown that Avastin does not affect overall survival for metastatic breast cancer patients and has significant side effects.
  • The FDA's review process for Avastin could take several months, leaving patients in limbo while they await a decision on the drug's continued availability.

Sources:

  • Susan G. Komen for the Cure (www.komen.org)
  • U.S. Food and Drug Administration (www.fda.gov)
  • Gene Therapy Weekly, (2010) via NewsRx.com
  • Susan G. Komen for the Cure, About Us, (accessed 2023)

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