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Briefing note: vemurafenib (Zelboraf)

SMC did not accept vemurafenib as monotherapy for the treatment of adult patients with BRAF V600 mutationpositive unresectable or metastatic melanoma.

  • Advanced melanoma is a type of skin cancer. When possible, melanoma is treated by removing the affected area surgically. A melanoma which cannot be removed in this way is said to be unresectable. A melanoma is metastatic if the cancer has spread to other parts of the body.
  • Vemurafenib inhibits a gene (called BRAF V600) which is overactive in approximately 50% of melanomas. It is given as a tablet taken by mouth twice daily.
  • A study in patients with previously untreated unresectable stage IIIC or stage IV melanoma with BRAF V600E mutation has shown that vemurafenib given by mouth improved overall survival and survival without progression of the disease, compared with another chemotherapy regimen given intravenously.
  • The most common adverse events occurring in a greater proportion of patients given vemurafenib were rash, increased reactivity of the skin to sunlight, hair loss, itching and joint pain.
  • SMC did not accept vemurafenib for use in NHSScotland because there were weaknesses in the economic case presented by the manufacturer and the balance of costs and benefits meant the medicine was not considered to offer value for money.