This week, the German Institute for Health Care Quality and Efficiency (IQWiG) said that Bayer’s Vitrakvi (larotrectinib), which had been approved in the EU last summer, was not shown to provide an added advantage.
Vitrakvi was the first drug licensed in the EU as a therapy for tumors with a specific mutation, irrespective of where the tumor developed in the body. But in three single-arm trials, the safety and efficacy of the procedure was tested, and IQWiG took issue with the lack of comparator weapons in the trials.
“In exceptional cases, experiments without comparator data may be necessary for approval if the goal is to demonstrate that the drug has a tumor effect. Nonetheless, if the issue is whether such an effect is correlated with a patient-relevant value, specific comparator data is needed, “IQWiG said.
As for overall survival, the Institute also found that the disparities between larotrectinib and other therapies reported so far “were not so significant in any of the cancer diseases that they could not be explained by systematic bias aloneAs for overall survival, the Institute also found that the disparities between larotrectinib and other therapies reported so far “were not so significant in any of the cancer diseases that they could not be explained by systematic bias alone.
Deficiencies in the histology-independent analyzes offered by Bayer have also been reported, as have a lack of preset analyzes and selective reporting of results.
Nonetheless, Bayer told Focus via email that it does not hold IQWiG’s views and is persuaded of the additional benefit “due to the extremely high efficacy and good tolerability shown in clinical trials for patients with so-called TRK fusion tumors.”
Bayer also said that IQWiG’s methods “are not yet suitable for testing histology-independent drugs, so this opinion is not shocking.” The company also noted that approval by the European Medicines Agency (EMA) is conditional so that “further clinical evidence will be produced through registries and non-interventional phase IV trials after the EMA approval.”