GSK receives positive CHMP opinions for Tafinlar


Regulatory Update – GSK for ® (dabrafenib) and Tyverb® (lapatinib)

LONDON, June 28, 2013 – Today, GlaxoSmithKline plc (GSK) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is recommending marketing authorisation for two cancer drugs. CHMP issued positive opinions for:

• Tafinlar® (dabrafenib) as treatment for adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

• 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.

About Tafinlar® (dabrafenib)

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 %) reported with dabrafenib were hyperkeratosis, headache, pyrexia, arthralgia, fatigue, nausea, papilloma, alopecia, rash and vomiting.

Important Safety Information for Tafinlar®

Pyrexia: Fever has been reported in clinical trials. Serious non-…Read more

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