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Pharmaceutical industry

FDA Revokes Accelerated Approval of Avastin for Breast Cancer Treatment

Strategic Insights

— 2 min read

The U.S. Food and Drug Administration (FDA) has revoked the accelerated approval of Genentech's cancer drug Avastin for the treatment of metastatic breast cancer, citing concerns over its safety and effectiveness. Despite this decision, Avastin will remain in the market as an approved treatment for certain types of cancer, such as colon, lung, kidney, and brain cancer. The FDA cited risks like high blood pressure, bleeding, and hemorrhaging as primary concerns for the drug's revocation. Genentech plans to conduct another trial to regain approval and continue to help breast cancer patients through its patient-support programs.

Key Takeaways:

  • The FDA revoked the accelerated approval of Avastin for metastatic breast cancer due to concerns over its safety and effectiveness.
  • Avastin will remain in the market as an approved treatment for certain types of cancer, including colon, lung, kidney, and brain cancer.
  • The FDA cited risks such as high blood pressure, bleeding, and hemorrhaging as primary concerns for the drug's revocation.
  • Genentech plans to conduct another trial to regain approval for Avastin's use in breast cancer treatment.
  • Avastin was granted accelerated approval in 2008, but subsequent studies showed it did not significantly increase life expectancy for breast cancer patients.
  • The FDA accelerated approval program provides earlier patient access to promising new drugs while confirmatory clinical trials are conducted.
  • Avastin's clinical trials have shown varying results, with some studies showing delayed tumor growth but not significantly increasing life expectancy.
  • The drug's unique mechanism of action, which works by choking off the blood supply to tumors, has been a primary reason for its approval and use in various cancer treatments.
  • Roche's acquisition of Genentech in 2009 was driven in part by Avastin's clinical heft and potential continued sales.
  • Analysts estimate that Roche could lose up to $1 billion in Avastin sales if approval to treat breast cancer is revoked.
  • Avastin has already lost its status as the world's best-selling cancer drug to Roche's own Rituxan, which has seen increased sales in recent years.

Statistics:

  • The FDA revoked the accelerated approval of Avastin for breast cancer treatment on November 18, 2011.
  • Avastin sales in the first nine months of 2011 were 3.942 billion Swiss francs, down 8% from the previous year.
  • U.S. sales of Avastin in the first nine months of 2011 were 1.774 billion Swiss francs, down 15% from last year.
  • Rituxan sales in the first nine months of 2011 were 4.4 billion Swiss francs, up 7% from last year.
  • U.S. sales of Rituxan in the first nine months of 2011 were 2.2 billion Swiss francs, up 6% from the previous year.
  • Roche's acquisition of Genentech in 2009 was for $47 billion.
  • Analysts estimate that Roche could lose up to $1 billion in Avastin sales if approval to treat breast cancer is revoked.

Sources:

  • Genentech, a part of Swiss drug giant Roche Holding AG (RHHBY.PK) (ROG.VX), statement on FDA revocation of Avastin's accelerated approval for breast cancer treatment.
  • FDA press release on the revocation of Avastin's accelerated approval for breast cancer treatment.
  • RTT News article "Roche's Avastin Loses Breast Cancer Approval, Still Available for Other Indications" published on November 18, 2011.

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