ASH News Daily - Sunday, December 11, 2011 - (Page A-3)

NOW APPROVED FOR BRAF V600E MUTATION-POSITIVE METASTATIC MELANOMA Visit ZELBORAF.com for more information Indication and Usage ZELBORAF™ (vemurafenib) is 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. Important Safety Information Cutaneous squamous cell carcinoma, serious hypersensitivity reactions including anaphylaxis, serious dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, QT prolongation, liver laboratory abnormalities, photosensitivity, ophthalmologic reactions, and new primary malignant melanoma have all been observed or associated with ZELBORAF treatment. ZELBORAF may cause fetal harm when administered to a pregnant woman based on its mechanism of action. Confirmation of BRAFV600E mutation-positive melanoma is required for selection of patients appropriate for ZELBORAF therapy. The most common adverse reactions of any grade (≥30%) reported were arthralgia, rash, alopecia, fatigue, photosensitivity reaction, nausea, pruritus, and skin papilloma. Please see brief summary of full Prescribing Information on the following page for additional important safety information or visit ZELBORAF.com for full Prescribing Information. © 2011 Genentech USA, Inc. All rights reserved BRF0000454600 Printed in USA. 

Table of Contents for the Digital Edition of ASH News Daily - Sunday, December 11, 2011

ASH News Daily - Sunday, December 11, 2011

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