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FDA Approves Zelboraf for Metastatic Melanoma with BRAF V600E Mutation

Strategic Insights

— 1 min read

Zelboraf (vemurafenib) has become the first and only FDA-approved personalized medicine to help people with BRAF V600E mutation-positive metastatic melanoma, a devastating disease that until now had limited approved treatment options. This approval is based on results from two clinical studies (BRIM3 and BRIM2) that demonstrated Zelboraf's effectiveness in improving survival and reducing the risk of disease progression.

Key Takeaways:

  • Zelboraf is the first and only FDA-approved personalized medicine shown to improve survival in people with BRAF V600E mutation-positive metastatic melanoma.
  • The FDA approval is based on results from two clinical studies: BRIM3 and BRIM2.
  • In BRIM3, the risk of death was reduced by 56 percent for people who received Zelboraf compared to those who received chemotherapy.
  • People who received Zelboraf also had a 74 percent reduced risk of the disease getting worse or dying (PFS) compared to those who received chemotherapy.
  • The confirmed investigator-assessed response rate in people who received Zelboraf was 48.4 percent, compared to 5.5 percent for those who received chemotherapy.
  • The cobas 4800 BRAF V600 Mutation Test, developed by Roche, is a diagnostic test that can identify patients eligible for treatment with Zelboraf.
  • Zelboraf may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC), which is usually non-life-threatening.
  • Patients should check their skin regularly and tell their doctor about any skin changes or new warts, skin sores, or reddish bumps that bleed or do not heal.
  • Common side effects of Zelboraf include joint pain, rash, hair loss, and sunburn or sun sensitivity.

Statistics:

  • More than 70,000 new cases of melanoma and nearly 8,800 melanoma deaths are expected in the United States this year.
  • A person with metastatic melanoma has an average life expectancy of just a few months.
  • The BRAF V600E mutation is found in an estimated half of all melanomas and eight percent of solid tumors.
  • The cobas 4800 BRAF V600 Mutation Test has improved sensitivity, accuracy, and speed compared to other commonly used methods, including Sanger sequencing.

Sources:

  • Genentech press release, "FDA Approves Zelboraf for Metastatic Melanoma with BRAF V600E Mutation"
  • National Cancer Institute, "Melanoma"
  • American Cancer Society, "Melanoma"
  • Roche press release, "Roche announces FDA approval of Zelboraf (vemurafenib) for the treatment of BRAF V600E mutation-positive, unresectable or metastatic melanoma"
  • FDA, "Zelboraf"

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