Roche files melanoma combo in USA

by | 15th Dec 2014 | News

Roche’s Genentech unit has filed cobimetinib in combination with already-marketed Zelboraf with regulators in the USA for the treatment of the deadliest form of skin cancer.

Roche’s Genentech unit has filed cobimetinib in combination with already-marketed Zelboraf with regulators in the USA for the treatment of the deadliest form of skin cancer.

Specifically, cobimetinib, a MEK inhibitor which has been developed with Exelixis, has been submitted to the US Food and Drug Administration for treatment, in combination with Zelboraf (vemurafenib), for people with BRAF V600 mutation-positive advanced melanoma. The filing is based on results of the coBRIM Phase III study, which showed that the combo improved progression-free survival compared to Zelboraf alone (9.9 versus 6.2 months).

Roche chief medical officer Sandra Horning said “in the past several years we have made significant progress in treating advanced melanoma, but it remains a serious and difficult to treat cancer that affects more people each year”. She hopes that the combo “will soon become a new option for people with BRAF mutation-positive advanced melanoma”.

Cobimetinib is also being investigated in combination with several investigational medis, including an immunotherapy, and in several tumour types such as non-small cell lung, colorectal and triple-negative breast cancers, as well as melanoma.

The American Cancer Society estimates there will be more than 76,100 new cases of melanoma and 9,700 deaths this year in the USA._

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