<code id='BF4C394852'></code><style id='BF4C394852'></style>
    • <acronym id='BF4C394852'></acronym>
      <center id='BF4C394852'><center id='BF4C394852'><tfoot id='BF4C394852'></tfoot></center><abbr id='BF4C394852'><dir id='BF4C394852'><tfoot id='BF4C394852'></tfoot><noframes id='BF4C394852'>

    • <optgroup id='BF4C394852'><strike id='BF4C394852'><sup id='BF4C394852'></sup></strike><code id='BF4C394852'></code></optgroup>
        1. <b id='BF4C394852'><label id='BF4C394852'><select id='BF4C394852'><dt id='BF4C394852'><span id='BF4C394852'></span></dt></select></label></b><u id='BF4C394852'></u>
          <i id='BF4C394852'><strike id='BF4C394852'><tt id='BF4C394852'><pre id='BF4C394852'></pre></tt></strike></i>

          fashion

          fashion

          author:fashion    Page View:5697
          The FDA building -- First Opinion coverage from STAT
          Adobe

          A panel of expert advisers to the Food and Drug Administration on Friday voted in favor of expanding the use of CAR-T therapy in blood cancer, despite concerns about the powerful treatment’s side effects.

          The group voted 11-0 that the benefits of Carvykti, a CAR-T medicine from Johnson & Johnson and Legend Biotech, outweighed its risk for patients with multiple myeloma whose disease has persisted despite initial treatment. The same panel voted 8-3 in favor of Abecma, from Bristol Myers Squibb and 2seventy Bio, for multiple myeloma patients who’ve received at least two lines of therapy. Currently both medicines are approved only for patients who have been treated for myeloma with four or more medications.

          advertisement

          In clinical trials, each drug proved to significantly delay disease progression compared to standard therapy. But zooming in on the data, the FDA observed an alarming imbalance of deaths in the early months of both studies, finding that more patients in the CAR-T group died of myeloma or side effects than those receiving the standard of care.

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

          Subscribe Log In

          explore

          ChatGPT in medicine: STAT answers readers' burning questions
          ChatGPT in medicine: STAT answers readers' burning questions

          MikeReddyforSTATArtificialintelligenceisoftendescribedasablackbox:anunknowable,mysteriousforcethatop

          read more
          Readout Newsletter: H5N1 bird flu vaccine, Cytokinetics, Gilead
          Readout Newsletter: H5N1 bird flu vaccine, Cytokinetics, Gilead

          Wanttostayontopofthescienceandpoliticsdrivingbiotechtoday? Signup togetourbiotechnewsletterinyourinb

          read more
          Jerome Adams on the need for new antivirals for Covid
          Jerome Adams on the need for new antivirals for Covid

          PaxlovidtabletsamplesbeinginspectedinFreiburg,Germany.PfizerviaAPTheU.S.Covid-19Public HealthEmergen

          read more

          UnitedHealth argues against case alleging wrongful AI care denials

          AdobeUnitedHealthGroupshouldbereleasedfromalawsuitthatallegesitsalgorithm-basedtechnologyprematurely