ZELBORAF (vemurafenib) tablet is a prescription medicine. ZELBORAF (vemurafenib) tablet is used to treat adults with unresectable or metastatic melanoma.
INDICATIONS AND USAGE
ZELBORAF is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
DOSAGE FORMS & STRENGTHS Tablet: 240 mg
Manufactured By: Genentech
Prescribing Information URL: Click Here
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Vemurafenib (INN, marketed as Zelboraf) is an inhibitor of the B-Raf enzyme developed by Plexxikon (now part of Daiichi-Sankyo) and Genentech for the treatment of late-stage melanoma. The name "vemurafenib" comes from V600E mutated BRAF inhibition.
Vemurafenib received FDA approval for the treatment of late-stage melanoma on August 17, 2011, making it the first drug designed using fragment-based lead discovery to gain regulatory approval.
Vemurafenib later received Health Canada approval on February 15, 2012.
On February 20, 2012, the European Commission approved vemurafenib as a monotherapy for the treatment of adult patients with BRAF V600E mutation positive unresectable or metastatic melanoma, the most aggressive form of skin cancer.
On November 6, 2017, the FDA approved Vemurafenib for the treatment of some patients with Erdheim–Chester disease (ECD), a rare type of histiocytic neoplasm.