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Daiichi submits melanoma drug applications

Daiichi Sankyo has submitted US and European marketing applications for a potential new drug to treat metastatic melanoma
Daiichi Sankyo has submitted US and European marketing applications for a potential new drug to treat metastatic melanoma, as well as for a DNA-based companion diagnostic to identify patients whose tumours carry the BRAF mutation targeted by the drug. 

The drug, vemurafenib, is an oral therapy that targets the oncogenic BRAF mutation, which is present in about half of melanoma cancers and about eight per cent of all solid tumours. 

Daiichi Sankyo acquired vemurafenib last month when it bought Plexxikon, a biotech company that discovered the drug and is co-developing it with Roche under a 2006 agreement. Plexxicon and Roche also co-developed the companion test under a separate collaboration agreement. 

If the drug is approved, Daiichi will co-promote it in the US with Roche's Genentech unit under an agreement previously signed between Plexxikon and Genentech. The product could become Daiichi's first marketed oncology therapy. 

"Daiichi Sankyo has brought on board a highly experienced sales team to co-promote vemurafenib with Genentech in the US, pending FDA approval, and we look forward to working with our partner to bring this new personalised approach to this deadly type of cancer to patients and providers," said president and CEO John Gargiulo.

The US and European marketing applications contain data from two clinical studies that evaluated vemurafenib in people with BRAF V600 mutation-positive metastatic melanoma, as determined by the cobas 4800 BRAF V600 Mutation Test.  

One of the studies, which tested vemurafenib against the chemotherapy drug dacarbazine was terminated early after the data safety monitoring board reviewed positive interim data and recommended that the study be stopped and the dacarbazine patients put on the newer drug. The second study demonstrated a 52 per cent confirmed response rate for vemurafenib, with tumour shrinkage in the majority of patients.

12th May 2011

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