Vemurafenib/BRAF V600E

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.