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First-in-class skin cancer drug approved

Daiichi Sankyo's Zelboraf, a first-in-class personalised oral treatment for patients with advanced melanoma, has received FDA approval

Daiichi Sankyo has received approval from the US Food and Drug Administration (FDA) for Zelboraf (vemurafenib), an oral, small-molecule kinase inhibitor, for the treatment of patients with unresectable or metastatic melanoma with the BRAF V600E mutation (as detected by the cobas 4800 BRAF V600 Mutation Test, which has also been newly approved by the FDA). Zelboraf is not recommended for use in melanoma patients who lack the BRAF V600E mutation.

The approval is based on the results of the BRIM3 and BRIM2 studies, which found that – compared with standard-of-care decarbazine chemotherapy – in patients being treated with Zelboraf the risk of death was reduced by 56 per cent, and the risk of the disease getting worse or the patient dying was reduced by 74 per cent. Response rate to Zelboraf was 52 per cent in BRIM2 and 48.4 per cent in BRIM3 (compared with 5.5 per cent for chemotherapy).

Zelboraf's potential serious side effects include severe allergic reactions, QT prolongation and eye problems. Zelboraf may also cause cutaneous squamous cell carcinoma (cuSCC), and patients taking Zelboraf should avoid exposure to sunlight.

“The Zelboraf approval is not only a significant milestone for these metastatic melanoma patients, but also for Daiichi Sankyo, and is an excellent example of the highly personalised approach to cancer treatment that can come through exploring multiple molecular pathways, unique discovery technology and advanced genetic insights,” said Dr Glenn Gormley, PhD, chief science officer and president, Daiichi Sankyo Pharma Development.  

This approval represents Daiichi Sankyo's first steps into the US oncology market. Zelboraf, which was discovered and developed by Plexxikon, will be co-promoted by Genentech in the US, where the drug is expected to be available through speciality pharmacies within two weeks.

The American Cancer Society estimates there will be more than 70,000 new cases of melanoma and nearly 8,800 melanoma deaths this year in the US. Other targeted pathways under investigation by Daiichi Sankyo include a c-MET inhibitor, a death receptor 5 (DR5) agonist, a PPAR gamma agonist, a selective kinase inhibitor and an anti-HER3 antibody, among others.

An application for market approval of vemurafenib (PLX4032) for the treatment of melanoma is under review by the European Medicines Agency (EMA).

18th August 2011

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