Vitakvi, Bayer's "broad spectrum" anticancer drug, was rejected in Britain and Germany

Recently, cost regulators in England and Germany rejected Bayer's application for the listing of vitrakvi (larotrecinib), mainly due to the high price of the drug and the limitations of clinical data The National Institute of health and care excellence (NICE) said in its draft guidance that the cost / benefit calculation of the expensive drug was "very uncertain" and that the benefits of the drug were not known relative to the existing treatment options Vitrakvi is the first oral Trk inhibitor, which is specially used to treat tumors with ntrk gene fusion At the end of November 2018, vitrakvi was approved by the US FDA for use in children and adults with advanced solid tumors carrying ntrk gene fusion This approval makes vitrakvi the first oral Trk inhibitor in history and the first "broad-spectrum" anticancer drug unrelated to tumor type In September 2019, vitrakvi was approved by the European Union As an oral highly selective Trk inhibitor, vitrakvi has been studied in clinical trials of 29 different histologic solid tumors, including lung, thyroid, melanoma, gastrointestinal stromal tumor, colon, soft tissue sarcoma, salivary gland and infant fibrosarcoma The results showed that the compound was effective for all age patients in primary central nervous system (CNS) tumors and brain metastases, regardless of the pathological type of the primary focus Although there is clinical evidence that the tumor volume of ntrk fusion in patients after vitrakvi treatment has been reduced, nice believes that vitrakvi is not compared with other therapies in the trial, so it is difficult to determine the therapeutic effect of vitrakvi Nice also said that vitrakvi's 30 day supply costs up to £ 15000, although Bayer offered a "commercial discount" for this, but the agency still believes that vitrakvi cannot potentially use the NHS resources in a cost-effective way "If Bayer reconsiders pricing vitrakvi, there is still room for further discussion," NHS commissioning director John Stewart said in a statement Stewart said the NHS is preparing for similar "next generation therapies," including a constructive dialogue with Roche on rozlytrek Although Bayer expressed disappointment with the decision, it was not surprised by the result, because "nice's method is not yet applicable to the evaluation of products independent of histology." Bayer said it would continue to negotiate with nice and hoped that the drug would receive positive evaluation feedback from nice in the future On the same day, IQWiG, the German regulator, rejected vitrakvi's application for listing in Germany due to insufficient actual data Reference source: Bayer's' tumor agnostic 'cancer Med vitrakvi turned away in England, Germany