• In August 2011, FDA approved the drug vemurafenib (Zelboraf) along with its companion diagnostic (BRAF V600E mutation test), for use in treating metastatic or unresectable melanoma.
  • Vemurafenib works by inhibiting the BRAF V600E mutation that is found in approximately 50% of melanoma patients.
  • Melanomas that lack the mutation are not inhibited by the drug.
  • The combination of drug and its diagnostic resulted in an accelerated development of the drug, facilitated a successful regulatory review, and led to an improved  therapeutic profile.
  • Vemurafenib was approved by FDA in near record time (3.6 months) through an expedited process.

Schedule a call