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    German drug assessment body not convinced by Bayer's cancer drug Vitrakvi

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2020-01-19T09:30:53+05:30  |  Updated On 19 Jan 2020 9:31 AM IST
    German drug assessment body not convinced by Bayers cancer drug Vitrakvi

    Frankfurt: 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 tumours 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, criticised 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 tumour 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 tumours.

    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.

    Read also: Granules India gets USFDA nod for allergy treatment drug Loratadine

    EMA, for its part, has said it was swayed in favour of Vitrakvi by trials involving 102 patients that showed that the drug reduced the size of tumours in 67% of cases, and by the speed of tumour 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.

    Read also: Bayer, Evotec collaborate to develop multiple clinical candidates to treat PCOS


    Source : Reuters

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    Medical Dialogues Bureau
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      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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