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Tuesday, 30 July 2019 00:10 - - {{hitsCtrl.values.hits}}
Reuters: Europe’s drug regulator has recommended approving Bayer’s Vitrakvi, putting the medicine on track to become the first in Europe to tackle tumours with a specific genetic mutation regardless of where in the body the disease started.
The drug is being recommended for adults and children with difficult to treat forms of cancer that are driven by a rare genetic mutation known as NTRK gene fusion, the European Medicines Agency (EMA) said on Friday (bit.ly/2Mi6s5o).
The European Commission has the final word on drug approvals but it generally follows EMA’s recommendation within a couple of months.
The EMA endorsement marks a boost for the German company’s drug development pipeline, which many analysts regard as too thin to make up for an expected decline in revenues from its two pharma bestsellers from about 2024.
The concept of a cancer drug’s use based on genetic growth drivers and not on the tumour’s location in the body received its first regulatory go-ahead in the US in 2017.
