Roche’s melanoma drug Zelboraf cleared in EU

Roche has said its Zelboraf drug has become the first personalised medicine for the skin cancer melanoma to be approved by the European Commission (EC).

Zelboraf (vemurafenib) has been given marketing authorisation as a single-agent therapy for adult patients with unresectable or metastatic melanoma who test positive for the BRAF V600 genetic mutation, the most aggressive form of skin cancer.

The mutated form of the BRAF protein occurs in about half of all melanoma cases and is detected by a polymerase chain reaction (PCR)-based diagnostic test.

Roche says that Zelboraf is the first targeted treatment that has been shown to extend survival in melanoma patients and improve their quality of life.

Data from the late-stage BRIM3 trial showed that the risk of death was reduced by 63 per cent for patients on Zelboraf compared to those who received standard first-line melanoma treatment.

In addition, Roche’s drug significantly improved survival by more than three months, at 13.2 months versus 9.6 months for chemotherapy.

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21.Feb.12 Personal

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