The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for GlaxoSmithKline's two cancer drugs: Tafinlar (dabrafenib) as treatment for adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation and Tyverb (lapatinib) in combination with trastuzumab as a treatment for adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2) with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy.
“We are delighted by the positive opinions issued by CHMP on lapatinib and dabrafenib. They represent evidence of our commitment to patients living with cancer and they could bring new treatment options for European patients living with specific types of advanced breast cancer and melanoma,” said Dr Rafael Amado, Head of Oncology R&D, GlaxoSmithKline.
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission, but does not always result in marketing authorisation.
Dabrafenib is not approved or licensed in the EU as treatment for adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The safety profile is based on data from five clinical monotherapy studies and included 578 patients with melanoma. The most frequently occurring adverse drug reactions (ADRs) (³ 15 per cent) reported with dabrafenib were hyperkeratosis, headache, pyrexia, arthralgia, fatigue, nausea, papilloma, alopecia, rash and vomiting.
Lapatinib is not approved or licensed in the EU in combination with trastuzumab for adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2) with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy.
In the phase III trial of lapatinib and trastuzumab compared to lapatinib alone in patients with HER2-positive metastatic breast cancer whose disease has progressed on trastuzumab-containing regimens, the most frequent adverse reactions (> 20%) during therapy with lapatinib and trastuzumab were diarrhoea (62%), nausea (28%), rash (23%), and fatigue (22 %).
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