<code id='2BD89F17B0'></code><style id='2BD89F17B0'></style>
    • <acronym id='2BD89F17B0'></acronym>
      <center id='2BD89F17B0'><center id='2BD89F17B0'><tfoot id='2BD89F17B0'></tfoot></center><abbr id='2BD89F17B0'><dir id='2BD89F17B0'><tfoot id='2BD89F17B0'></tfoot><noframes id='2BD89F17B0'>

    • <optgroup id='2BD89F17B0'><strike id='2BD89F17B0'><sup id='2BD89F17B0'></sup></strike><code id='2BD89F17B0'></code></optgroup>
        1. <b id='2BD89F17B0'><label id='2BD89F17B0'><select id='2BD89F17B0'><dt id='2BD89F17B0'><span id='2BD89F17B0'></span></dt></select></label></b><u id='2BD89F17B0'></u>
          <i id='2BD89F17B0'><strike id='2BD89F17B0'><tt id='2BD89F17B0'><pre id='2BD89F17B0'></pre></tt></strike></i>

          focus

          focus

          author:fashion    Page View:39
          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

          focus

          Moonlake's readout produced a cash windfall. Risks remain
          Moonlake's readout produced a cash windfall. Risks remain

          MollyFerguson/STATFortwodaysstartingonSunday,MoonlakeImmunotherapeuticshappilycrunchednumbersandshar

          read more
          Amylyx ALS drug fails trial: Relyvrio patients react with fear, worry
          Amylyx ALS drug fails trial: Relyvrio patients react with fear, worry

          GwenPetersen,38,anALSpatient,believesthattherecentfailureofAmylyx'sdrugRelyvriocouldstillteachresear

          read more
          Duchenne breakthrough therapy leaves behind pioneering families
          Duchenne breakthrough therapy leaves behind pioneering families

          DuchennemusculardystrophyDr.EdwinP.Ewing,Jr./CDCPatFurlongwassittinginherhomeofficeinMiddletown,Ohio

          read more

          Obesity drug from Roche shows promise in early study

          SebastienBozon/AFPviaGettyImagesLONDON—RocheonThursdaysaiditsrecentlyacquiredexperimentalobesitymedi