<code id='EB249B241F'></code><style id='EB249B241F'></style>
    • <acronym id='EB249B241F'></acronym>
      <center id='EB249B241F'><center id='EB249B241F'><tfoot id='EB249B241F'></tfoot></center><abbr id='EB249B241F'><dir id='EB249B241F'><tfoot id='EB249B241F'></tfoot><noframes id='EB249B241F'>

    • <optgroup id='EB249B241F'><strike id='EB249B241F'><sup id='EB249B241F'></sup></strike><code id='EB249B241F'></code></optgroup>
        1. <b id='EB249B241F'><label id='EB249B241F'><select id='EB249B241F'><dt id='EB249B241F'><span id='EB249B241F'></span></dt></select></label></b><u id='EB249B241F'></u>
          <i id='EB249B241F'><strike id='EB249B241F'><tt id='EB249B241F'><pre id='EB249B241F'></pre></tt></strike></i>

          comprehensive

          comprehensive

          author:comprehensive    Page View:983
          The FDA building -- First Opinion coverage from STAT
          Adobe

          The clearance of a first-of-its-kind cancer treatment made by Amgen is on shakier ground following a Food and Drug Administration advisory committee meeting Thursday.

          Regulatory advisers voted 10-2 that the data on the company’s drug Lumakras, a treatment for lung cancer, could not be properly assessed. Lumakras targets a specific mutation to a protein called KRAS, which is one of the most common genetic mutations in cancer.

          advertisement

          The vote comes as Amgen is hoping to convert a conditional approval for the drug to a full approval based on a 345-person study called CodeBreaK 200, in which Lumakras met the primary endpoint, delaying tumor growth approximately five weeks longer than the standard of care medication, docetaxel. The drug didn’t extend patients’ overall survival.

          Get unlimited access to award-winning journalism and exclusive events.

          Subscribe Log In

          explore

          How to save PrEP access — and even expand it
          How to save PrEP access — and even expand it

          UndertheAffordableCareAct,healthinsurersarerequiredtocoverallcostsassociatedwithpreventivecare—inclu

          read more
          Duchenne patients, backed by ‘dark money’ group, to debate drug prices
          Duchenne patients, backed by ‘dark money’ group, to debate drug prices

          ICERPresidentStevenD.PearsonCraigF.Walker/TheBostonGlobeMeetingsoftheInstituteforClinicalandEconomic

          read more
          Hollywood unions extend contract negotiations for actors
          Hollywood unions extend contract negotiations for actors

          1:36HollywoodwritersandtheirsupportersfromtheSAGAFTRAactors'unionwalkthepicketlineoutsideWarnerBrosS

          read more

          The Jan. 6 committee previously recommended Trump be criminally charged. Here's why

          8:14FormerU.S.PresidentDonaldTrumpisdisplayedonascreenduringameetingoftheSelectCommitteetoInvestigat