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Mekinist shown green light by CHMP

Published on 28/04/14 at 08:02am
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GlaxoSmithKline’s melanoma drug Mekinist is virtually nailed on to be given approval in the European Union following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

Barring the unexpected, the authorisation of Mekinist (trametinib) will be rubber-stamped by the European Commission in the next few months, and the drug will be available as monotherapy in adults with unresectable or metastatic melanoma with a BRAF V600 mutation.

GSK will be pleased, as will Novartis: the MEK inhibitor transfers to the Swiss group’s ownership next year as a multi-billion dollar deal between the companies goes through.

Novartis will have control of the whole of GSK’s cancer portfolio, while GSK takes over Novartis’ vaccines business.

Rafael Amado, head of oncology R&D at GSK, says: “This CHMP opinion brings us a step closer to making another personalised medicine available for patients with BRAF-mutant metastatic melanoma in Europe.”

Mekinist has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy but it is already approved as a single agent and in combination with GSK’s own Tafinlar (dabrafenib) in the US and Australia, and as monotherapy in Canada.

The CHMP also had good news for Bayer and Amgen subsidiary Onyx Pharmaceuticals, recommending Nexavar (sorafenib) for use in thyroid cancer to delay the spread of the disease.

US regulators gave it the thumbs up in this indication in November, and the drug has an orphan designation from the European Commission for follicular and papillary thyroid cancer.

These types, including Hürthle cell, account for approximately 94% of all thyroid cancers, and those which are refractory to radioactive iodine are harder to treat.

The CHMP decision means the oral multi-kinase inhibitor should be approved soon in the EU in patients with RAI-refractory progressive, locally-advanced or metastatic, differentiated thyroid carcinoma.

“[It] is an important milestone because it brings patients one step closer to a new treatment option for this difficult-to-treat form of thyroid cancer,” says Joerg Moeller, Bayer’s head of global development.

Nexavar is already approved in hepatocellular carcinoma and advanced renal cell carcinoma in various countries, and Bayer argues that this third indication addresses a serious unmet medical need.

Elsewhere, European regulators are also likely to hand an extension to Boehinger Ingelheim’s multi-indication brand Pradaxa, after the CHMP showed it the green light to treat deep vein thrombosis and pulmonary embolism and prevention of repeat blood clots.

The drug is already approved for stroke prevention in patients with atrial fibrillation and the prevention of venous thromboembolism in people having hip or knee replacements.

“We aim to offer physicians and patients a new, simple treatment option that is as effective as warfarin, the current standard of care, while providing a favourable overall safety profile,” says Klaus Dugi, Boehringer’s chief medical officer.

Adam Hill 

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