<code id='49AC0294E7'></code><style id='49AC0294E7'></style>
    • <acronym id='49AC0294E7'></acronym>
      <center id='49AC0294E7'><center id='49AC0294E7'><tfoot id='49AC0294E7'></tfoot></center><abbr id='49AC0294E7'><dir id='49AC0294E7'><tfoot id='49AC0294E7'></tfoot><noframes id='49AC0294E7'>

    • <optgroup id='49AC0294E7'><strike id='49AC0294E7'><sup id='49AC0294E7'></sup></strike><code id='49AC0294E7'></code></optgroup>
        1. <b id='49AC0294E7'><label id='49AC0294E7'><select id='49AC0294E7'><dt id='49AC0294E7'><span id='49AC0294E7'></span></dt></select></label></b><u id='49AC0294E7'></u>
          <i id='49AC0294E7'><strike id='49AC0294E7'><tt id='49AC0294E7'><pre id='49AC0294E7'></pre></tt></strike></i>

          focus

          focus

          author:explore    Page View:53982
          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

          knowledge

          The cancer drug shortage isn’t new — and neither are the solutions
          The cancer drug shortage isn’t new — and neither are the solutions

          PreparingachemotherapytreatmentatDukeCancerCenterinDurham,N.C.GerryBroome/APAyounggirl,maybe5or6year

          read more
          Surprise medical billing ban raises prices elsewhere
          Surprise medical billing ban raises prices elsewhere

          ANGELAWEISS/AFPviaGettyImagesWithoutquestion,thenewfederallawbanningsurprisebillingisachievingitsgoa

          read more
          Trump demands the U.S. pay no more for drugs than other countries … again
          Trump demands the U.S. pay no more for drugs than other countries … again

          EthanMiller/GettyImagesWASHINGTON—FormerPresidentTrumpisbacktocampaigningfortyingMedicaredrugpricest

          read more

          Secretariat’s lessons for human medicine

          MollyFergusonforSTATSTATnowpublishesselectedLetterstotheEditorreceivedinresponsetoFirstOpinionessays