German drug assessment body not convinced by Bayer cancer drug Vitrakvi

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.

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.

https://www.reuters.com/article/us-bayer-vitrakvi-germany/german-drug-assessment-body-not-convinced-by-bayers-cancer-drug-vitrakvi-idUSKBN1ZF211