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Zelboraf

DrugZelboraf (Vemurafenib) [Genentech]

October 2007

Therapeutic Area - Oncology

Approval criteria

  • Patient has unresectable or metastatic melanoma AND
  • serine-threonine protein kinase BRAF (BRAF) V600E mutation as detected by a BRAF V600 Mutation Test

Quantity Limit: Quantity requested should be no greater than 240 tablets per fill; duration of approval 6 months.

Background information

Vemurafenib (Zelboraf) is an oral kinase inhibitor, indicated for the treatment of unresectable or metastatic melanoma with the serine-threonine protein kinase BRAF (BRAF) V600E mutation as detected by an FDA-approved test. Vemurafenib is not recommended for use in patients with wild-type BRAF melanoma. Vemurafenib has been approved with the cobas® 4800 BRAF V600 Mutation Test manufactured by Roche Molecular Systems. It is a companion diagnostic test, which will determine whether patients express the BRAF V600E mutation.

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411

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