Europe’s drug regulator has suggested that Bayer’s Vitrakvi be approved, making the medicine the first in Europe to deal with tumors with a particular genetic mutation irrespective of where the disease began in the body.
The drug is recommended for adults and kids with difficult cancer types caused by a rare genetic mutation known as NTRK gene fusion, the European Medicines Agency (EMA) said on Friday.
The European Commission has the final word on drug approvals, but it usually follows the suggestion of EMA within a few months. The EMA approval is a boost to the drug development pipeline of the German company, which is considered by many analysts to be too small to compensate for the anticipated decrease in profits from its two bestsellers of pharmaceuticals from around 2024.
In 2017, the idea of the use of a cancer drug based on genetic growth drivers and not on the place of the tumor in the body got its first legislative go-ahead in the US. At the moment, the U.S. approval was earned by Merck & Co’s Keytruda immunotherapy for this therapy strategy, also known as tumor-agnostic, Food and Drug Administration.
The extremely focused strategy has been shown to combat sophisticated disease, but so far drugmakers have pursued only very unusual genetic triggers. For example, NTRK fusions only cause cancer development in roughly 0.5 to 1.0% of strong tumors. The identification of these patients needs sophisticated diagnostic instruments that are still being fine-tuned or, if accessible, still need to be used widely among oncologists.
