ZELBORAF (vemurafenib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAFV600E mutation as detected by an FDA-approved test. ZELBORAF is not recommended for use in patients with wild-type BRAF melanoma. Dosage forms: Film-coated tablet: 240 mg. The recommended dose is 960 mg orally twice daily, administer ZELBORAF approximately 12 hours apart with or without a meal. It should be swallowed whole with a glass of water and it should not be chewed or crushed. Management of symptomatic adverse drug reactions may require dose reduction, treatment interruption, or treatment discontinuation of ZELBORAF. Dose reductions resulting in a dose below 480 mg twice daily are not recommended. In clinical trials Zelboraf was compared to the standard treatment of dacarbazine and was shown to improve progression free survival times by around four months, and overall survival times by about three months. The CHMP looked at the risks of using the drug, which include the possibility of secondary neoplasms, including squamous cell carcinoma, but decided that the magnitude of risk is acceptably low. They also recommended that Roche had put in place the appropriate risk management so that the chances of secondary cancers can be managed by physicians, who can carry out routine monitoring of patients.
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