Genentech Medicine Approved For Certain Type Of Melanoma

August 17th, 2011

On August 17, 2011, Zelboraf® (vemurafenib) was approved by the FDA for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma, as determined by an FDA-approved test. A diagnostic test developed by Roche to identify patients eligible for Zelboraf treatment was also approved.


Important Safety Information

ZELBORAF can cause serious side effects, including risk of new cancers. ZELBORAF may cause certain types of skin cancer called cutaneous squamous cell carcinoma (cuSCC) and keratoacanathoma. New melanoma lesions have occurred in people who take ZELBORAF. ZELBORAF may also cause another type of cancer called non-cutaneous squamous cell carcinoma (non-cuSCC). Talk with your healthcare provider about your risk for these cancers. Check your skin and tell your healthcare provider about skin changes, including a new wart, a sore or bump that bleeds or does not heal, or a mole that changes size or color.

Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that you get while taking ZELBORAF.

While taking ZELBORAF, you should avoid sunlight. When you go outside, wear clothes that protect your skin, including your head, face, hands, arms, and legs. Use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.

Possible serious side effects of ZELBORAF include severe allergic reactions, severe skin reactions, potentially life-threatening changes in the electrical activity of your heart called QT prolongation, liver injury, eye problems, worsening side effects from radiation treatment, kidney injury, and connective tissue disorders.

Tell your healthcare provider if you are pregnant, or plan to become pregnant, as ZELBORAF can harm your unborn baby. Females who are able to become pregnant should use effective birth control during ZELBORAF treatment and for 2 weeks after the final dose.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with ZELBORAF and for 2 weeks after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take.

Common side effects of ZELBORAF include joint pain, rash, hair loss, tiredness, sunburn or sun sensitivity, nausea, itching, or warts.

These are not all of the possible side effects of ZELBORAF. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see accompanying Full Prescribing Information and Medication Guide for additional Important Safety Information.