May 18, 2018 / 4:23 PM / 6 months ago

BRIEF-FDA Issues Alert On Use Of Keytruda/Tecentriq For Patients With Urothelial Cancer, Have Low Expression Of PD-L1

May 18 (Reuters) - FDA:

* U.S. FDA - ISSUES ALERT ABOUT DECREASED SURVIVAL ASSOCIATED WITH THE USE OF KEYTRUDA (PEMBROLIZUMAB) OR TECENTRIQ (ATEZOLIZUMAB)

* U.S. FDA SAYS THERE WAS NO CHANGE IN THE ADVERSE EVENT PROFILE OF KEYTRUDA OR TECENTRIQ

* FDA - MERCK, GENENTECH HAVE STOPPED ENROLLING PATIENTS WHOSE TUMORS HAVE PD-L1 LOW STATUS TO KEYTRUDA/TECENTRIQ MONOTHERAPY ARMS PER DMCS’ RECOMMENDATIONS

* U.S. FDA SAYS MONOTHERAPY ARMS REMAIN OPEN ONLY TO PATIENTS WHOSE TUMORS HAVE PD-L1 HIGH STATUS

* U.S. FDA - COMBINATION ARMS AND THE CHEMOTHERAPY ARMS OF BOTH STUDIES ALSO REMAIN OPEN

* FDA - ISSUED ALERT ON KEYTRUDA/TECENTRIQ AS MONOTHERAPY FOR PATIENTS WITH UROTHELIAL CANCER WHO HAVE NOT RECEIVED PRIOR THERAPY, HAVE LOW EXPRESSION OF PD-L1 Source text : (bit.ly/2k9egH8) Further company coverage:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below