Roche’s Zelboraf receives EU approval for the treatment of people with deadly form of skin cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY), today announced that the European Commission has approved Zelboraf (vemurafenib) as a monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma, the most aggressive form of skin cancer. Zelboraf is designed to target and inhibit mutated forms of the BRAF protein found in about half of all cases of melanoma.

“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.

In pivotal clinical trials, Zelboraf is the only treatment to benefit patient survival in both previously untreated and previously treated people with advanced melanoma who tested positive for BRAF V600 mutations using the Roche cobas 4800 BRAF V600 Mutation Test.

- In the pre-specified interim analysis of the phase III BRIM3 trial, the risk of death was reduced by 63 percent for people who received Zelboraf compared to those who received standard first-line treatment (hazard ratio [HR]=0.37, p<0.0001).

- In a post-hoc analysis of BRIM3 data with a longer follow up compared to previous analyses, including cross-over of patients from the placebo to the active treatment arm, Zelboraf significantly improved survival over standard first-line treatment by providing a median overall survival (OS) of 13.2 months compared to 9.6 months for chemotherapy (hazard ratio [HR]=0.62)

- A survival benefit was also shown in pre-treated patients in the phase II BRIM2 study, the data from which is planned to be published shortly.

In 2011, Zelboraf became the first and only US FDA approved personalised medicine that is shown to improve survival for people with BRAF V600 mutation-positive unresectable or metastatic melanoma. The cobas 4800 BRAF V600 Mutation Test, a diagnostic test co- developed by Roche to identify patients eligible for treatment, was approved simultaneously with Zelboraf in the US, and is CE-marked and commercially available in the EU.

Zelboraf has also recently been approved in Switzerland, Brazil, Israel, Canada and New Zealand and marketing authorization submissions are currently under review by health authorities in Australia, India and other countries worldwide. While Roche seeks regulatory approval of Zelboraf in other countries, a global safety study is providing access to Zelboraf for over 2000 people with previously treated or untreated BRAF V600 mutation-positive metastatic melanoma.

Zelboraf safety
The safety profile of Zelboraf was generally consistent in all clinical studies. The most common grade 3 or higher adverse events seen more often in people receiving Zelboraf compared to those receiving chemotherapy were a common type of skin cancer, cutaneous squamous cell carcinoma (cSCC) including keratoacanthomas, rash, liver function abnormalities, joint pain and sensitivity to the sun. In cases of cSCC, the lesions were generally removed and the patients continued with treatment.


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