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news.GlaxoSmithKline plc (GSK) has obtained positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for marketing authorisation of two cancer drugs, Tafinlar and Tyverb.
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Tafinlar (dabrafenib) is recommended as treatment for adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Tyverb (lapatinib) is recommended as combination therapy with trastuzumab as a treatment for adult patients with breast cancer, whose tumours overexpress HER2 with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) along with chemotherapy.
GlaxoSmithKline oncology R&D head Dr Rafael Amado said 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," Amado added.
Five clinical monotherapy studies, which involved 578 patients with melanoma, demonstrated safety profile of Tafinlar with hyperkeratosis, headache, pyrexia, arthralgia, fatigue, nausea, papilloma, alopecia, rash and vomiting as most frequently occurring adverse drug reactions.
The most frequent adverse reactions during therapy with lapatinib and trastuzumab in the Phase III trial were diarrhoea, nausea, rash, and fatigue.