BENGALURU: 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.
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 United States in 2017.
At the time, it was Merck & Co’s immunotherapy Keytruda that won approval from the US Food and Drug Administration for this treatment approach, which is also known as tumour-agnostic.
The highly targeted approach has been shown to fight back advanced disease but only very rare genetic triggers have been pursued by drugmakers so far.
NTRK fusions, for instance, trigger cancer growth only in about 0.5 to 1.0% of solid tumours. Identifying those patients requires advanced diagnostic tools that are still being fine-tuned or – if available – have yet to win wide-spread use among oncologists.
“As researchers learn more about tumour genomics, it becomes all the more important to ensure broad access to genomic testing to allow patients that have the potential to benefit from precision medicines to be identified and treated,” Scott Fields, Bayer’s head of oncology development, said in a statement.
Bayer earlier this year took full control of Vitrakvi in a deal with Eli Lilly’s Loxo Oncology, and the European thumbs-up follows US regulatory approval in November.
The company’s stock has slumped amid lawsuits over its Roundup weed killer, which it acquired after it bought US seed company Monsanto.
Bayer clinched the initial Loxo deal for Vitrakvi, also known as larotrectinib, in November 2017.