Archive | European Approval

Cobimetinib in melanoma with BRAF V600 mutation: Indication of minor added benefit

Cobimetinib (trade name: Cotellic) has been approved since November 2015 in combination with vemurafenib for the treatment of adults with advanced, i.e. metastatic or unresectable, melanoma with a BRAF V600 mutation. The Federal Joint Committee (G-BA) therefore commissioned the German Institute for Quality and Efficiency in Health Care (IQWiG) to examine whether cobimetinib in combination […]

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Posted in European Approval, Cancer in the News

T-VEC Approved in Europe for Unresectable Metastatic Melanoma

The European Commission has approved talimogene laherparepvec (T-VEC; Imlygic) as a treatment for adult patients with unresectable stage IIIb, IIIc, and IVM1a melanoma that has not spread to the bone, brain, lung, or other viscera, based on the phase III OPTiM study.

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Posted in Latest Research, European Approval, Cancer in the News, case study

Dabrafenib/Trametinib Combo Granted EU Approval for Advanced Melanoma

The combination of dabrafenib (Tafinlar) plus trametinib (Mekinist) has been approved by the European Commission for the treatment of patients with unresectable or metastatic BRAF V600­–positive melanoma, according to a statement from the drugs’ developer, Novartis.

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Posted in Latest Research, European Approval, Cancer in the News

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