Zelboraf for metastatic melanoma was approved by the European Commission

Zelboraf (vemurafenib) has received approval from the European Commission to be used as monotherapy for the treatment of adult patients with BRAFV600 mutation-positive inoperable or metastatic melanoma.

Its companion diagnostic, the cobas 4800 BRAF V600 Mutation Test is CE marked and commercially available in Europe.

“The approval of Zelboraf by the European Commission marks a significant advancement for European patients with metastatic melanoma who historically have had very limited treatment options. We are very pleased that our strategy to co-develop Zelboraf along with a companion diagnostic helped accelerate the availability of this personalized medicine for these patients,” said K. Peter Hirth, Ph.D., chief executive officer of Plexxikon.

Vemurafenib selectively inhibits the BRAF mutation that appears in around 50% of cases of melanoma and it is not recommended for use in melanoma patients without the BRAFV600 mutation.

“Today’s approval is important news for people with BRAF mutation-positive metastatic melanoma as Zelboraf significantly improves patient survival and exemplifies the benefits that Roche’s personalized approach to medicine can provide for patients, physicians and society,” said Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development.

According to the American Cancer Society, melanoma is one of the deadliest cancers, with a five-year survival rate of 15-20% for people with advanced (Stage IV) melanoma. Every year, over 160,000 people worldwide and more than 75,000 people in the United States are diagnosed with melanoma.

Multiple clinically atypical moles or dysplastic nevi, fair skin and sun exposure, prior melanoma, inherited genetic mutations, a positive family history of melanoma are the risk factors.

The BRAF gene is essential in normal cell growth and survival. BRAF mutations may lead to uncontrolled cell growth. These mutations can be found in around 50% of melanoma and in 8% of solid tumors.

Zelboraf has proven to be effective in BRIM3, a global, randomized, open-label, controlled, multicenter, Phase 3 study.

The study enrolled 675 patients with untreated BRAFV600E mutation-positive, unresectable (inoperable) or metastatic melanoma.

Zelboraf was compared to dacarbazine (chemotherapy) and an interim analysis showed the risk of death was reduced by 63% for patients who received Zelboraf.

In January 2011, the data safety monitoring board for BRIM3 recommended termination of the BRIM3 study due to compelling efficacy data, and further recommended that study patients receiving chemotherapy have the option to cross over to the vemurafenib treatment arm.

In a later analysis of BRIM3 data, including cross-over of patients from the chemotherapy treatment arm to the Zelboraf treatment arm, median overall survival was 13.2 months for Zelboraf, the risk of death was reduced by 38%. Median overall survival was 9.6 months for chemotherapy. Patients with metastatic melanoma have had a median survival of six to ten months.

At 12 months, in the Zelboraf treatment arm 55% of patients were alive and in the chemotherapy treatment arm 43%.

More information about ongoing vemurafenib studies is available at www.clinicaltrials.gov (in the U.S.) or www.clinicaltrialregister.eu or on the Roche Clinical Trials Registry at www.roche-trials.com (in the EU). Genentech can also be contacted by calling the company’s clinical trial call center at 1-888-662-6728 or emailing Genentech@druginfo.com.

Vemurafenib along with its companion diagnostic test was approved by the Food and Drugs Administration in August 2011 and is being marketed in the United States as Zelboraf for the treatment of patients with BRAFV600E mutation-positive inoperable or metastatic melanoma.

The cobas 4800 BRAF V600 Mutation Test, a DNA, polymerase chain reaction-based companion diagnostic, it is used to identify patients whose tumors carry the BRAF mutation.

The drug also has been approved by the European Commission, and in Switzerland, Israel, Brazil, New Zealand and Canada.

Marketing authorization submissions for Zelboraf are currently under review by health authorities in Australia, India, Mexico and other countries worldwide.

Zelboraf is being co-promoted by Daiichi Sankyo, Inc. and Genentech, a member of the Roche Group. Roche promotes Zelboraf outside of the United States.

Important Safety Information about Zelboraf (vemurafenib)

This information does not take the place of the patient talking to his or her doctor about their medical condition or their treatment with Zelboraf.

Zelboraf is a prescription medicine used to treat a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal “BRAF” gene.

Zelboraf may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC), that usually does not spread to other parts of the body. Patients should check their skin and tell their doctor about skin changes including a new wart, a skin sore or reddish bump that bleeds or does not heal, or a mole that changes size or color.

While taking Zelboraf, patients should avoid going out in the sun. When patients go outside, they should wear clothes that protect their skin, including head, face, hands, arms and legs. They should use lip balm and a broad-spectrum UVA/UVB sunscreen with SPF 30 or higher.

Possible serious side effects of Zelboraf include severe allergic reactions; severe skin reactions; changes in the electrical activity of the heart called QT prolongation, which can potentially be life-threatening; abnormal liver function tests; eye problems; or new melanoma lesions.

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. Patients must tell their doctor if they have any side effect that bothers them or does not go away. For more information about side effects, patients should ask their doctor or pharmacist.

Patients should call their doctor for medical advice about any side effects. Patients or their caregivers are encouraged to report negative side effects of prescription drugs to the FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. They may also report side effects to Genentech at 1-888-835-2555.

Patients should read the Zelboraf full Prescribing Information and Medication Guide for additional important safety information at www.zelboraf.com.

About Zelboraf (video):