<code id='5C97CF475C'></code><style id='5C97CF475C'></style>
    • <acronym id='5C97CF475C'></acronym>
      <center id='5C97CF475C'><center id='5C97CF475C'><tfoot id='5C97CF475C'></tfoot></center><abbr id='5C97CF475C'><dir id='5C97CF475C'><tfoot id='5C97CF475C'></tfoot><noframes id='5C97CF475C'>

    • <optgroup id='5C97CF475C'><strike id='5C97CF475C'><sup id='5C97CF475C'></sup></strike><code id='5C97CF475C'></code></optgroup>
        1. <b id='5C97CF475C'><label id='5C97CF475C'><select id='5C97CF475C'><dt id='5C97CF475C'><span id='5C97CF475C'></span></dt></select></label></b><u id='5C97CF475C'></u>
          <i id='5C97CF475C'><strike id='5C97CF475C'><tt id='5C97CF475C'><pre id='5C97CF475C'></pre></tt></strike></i>

          Wikipedia

          Wikipedia

          author:hotspot    Page View:1
          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

          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
          Dramatically reducing cancer deaths requires the PASTEUR Act
          Dramatically reducing cancer deaths requires the PASTEUR Act

          ThesuperbugStaphylcocusepidermidisisshownonanagarplate.Morethan3millionAmericansdevelopadrug-resista

          read more
          Psychedelics group wrestles with new pharma identity
          Psychedelics group wrestles with new pharma identity

          OliviaGoldhill/STATDENVER—Hecouldhavebeenarockstar,areligiousicon,thewayecstaticapplausefromthousand

          read more

          HPV cancer vaccine study demonstrates efficacy

          JoeRaedle/GettyImagesVaccinesworkwelltopreventcancerscausedbythehumanpapillomavirus(HPV).Sowell,infa