FRANKFURT (Reuters) – Germany’s drug assessment body said that data provided by Bayer on its precision cancer drug Vitrakvi did not provide clear enough evidence of benefits, in a setback to the drugmaker in its home market.
Bayer’s Vitrakvi won European approval in September, the first drug in Europe to tackle tumors based on a rare genetic mutation regardless of where in the body the disease started.
Bayer has said it expected annual peak sales of more than 750 million euros ($836 million) from the drug. It needs a boost as many analysts regard the group’s drug development pipeline as too thin to make up for an expected decline in revenues from its two bestsellers from about 2024.
IQWiG – an independent authority that evaluates new drugs and plays an advisory role over what price German health services pay for them – in particular criticized the fact that the clinical trials lacked a comparative group that did not receive Vitrakvi.
“In the future we need reliable comparable data for a benefit assessment of therapies across tumor types,” IQWiG said on its website late on Wednesday.
A Bayer spokeswoman said the genetic profile that Vitrakvi was targeting was too rare to allow for a control group.
The genetic change in question, known as NTRK gene fusion, occurs only in about 0.5% to 1% of patients with solid tumors.
IQWiG has been critical for years about insufficient trial data on new drugs, rejecting some pivotal studies that had convinced the European Medicines Agency (EMA) to approve a drug.
EMA, for its part, has said it was swayed in favor of Vitrakvi by trials involving 102 patients that showed that the drug reduced the size of tumors in 67% of cases, and by the speed of tumor shrinkage.
Germany is the largest European pharmaceuticals market and the fourth biggest globally. Still, it has only slightly more than 10% the size of the U.S. market, where Vitrakvi was approved in late 2018.
(Reporting by Ludwig Burger; Editing by Elaine Hardcastle)