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    Astellas, Seattle Genetics cancer drug Padcev gets speedy nod from USFDA

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-12-19T09:30:18+05:30  |  Updated On 19 Dec 2019 9:30 AM IST

    The drug, Padcev, is the first USFDA approved treatment in the United States for patients with advanced or metastatic urothelial cancer, Astellas Pharma Inc and Seattle Genetics said.


    New Delhi: U.S. Food and Drug Administration said on Wednesday it approved Astellas Pharma Inc and Seattle Genetics' experimental drug to treat advanced bladder cancer, about three months ahead of schedule.


    Shares of Seattle Genetics were up 6% at $119.05 after the bell.


    The drug, Padcev, is the first FDA approved treatment in the United States for patients with advanced or metastatic urothelial cancer, the companies said.


    The drug will treat patients with advanced bladder cancer whose disease has progressed even after treatment with immunotherapy and chemotherapy.


    The American Cancer Society estimates 17,670 people will die from bladder cancer in the United States this year.


    Read Also: Pfizer, Astellas Pharma get USFDA nod for prostate cancer therapy Xtandi


    The continued approval of the drug may depend upon verification of clinical benefit in confirmatory trials, the companies said, adding that a late-stage study is underway.


    The FDA's accelerated approval program allows conditional approval of a medicine that fills an unmet medical need for a serious condition.


    Read Also: Astellas Pharma to buy Audentes Therapeutics for USD 2.7 billion

    American Cancer SocietyAstellasAstellas Pharmabladder cancer drugcancerchemotherapyclinical studyimmunotherapyMetastatic urothelial cancerPadcevSeattle GeneticsUSFDA
    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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