March 27, 2020 / 6:17 AM / 8 days ago

BRIEF-Sanofi says receives positive CHMP opinion for Sarclisa

March 27 (Reuters) - Sanofi SA:

* SANOFI RECEIVES POSITIVE CHMP OPINION FOR SARCLISA® (ISATUXIMAB) FOR THE TREATMENT OF RELAPSED AND REFRACTORY MULTIPLE MYELOMA

* POSITIVE CHMP OPINION BASED ON DATA FROM ICARIA-MM, FIRST RANDOMIZED PHASE 3 TRIAL TO EVALUATE AN ANTI-CD38 IN COMBINATION WITH POM-DEX

* SARCLISA WAS APPROVED BY FDA ON MARCH 2 IN COMBINATION WITH POM-DEX FOR TREATMENT OF CERTAIN ADULTS WITH RRMM

* SANOFI - EUROPEAN COMMISSION (EC) WILL REVIEW CHMP RECOMMENDATION AND A FINAL DECISION ON MARKETING AUTHORISATION APPLICATION FOR SARCLISA IN E.U. IS EXPECTED IN COMING MONTHS

* SANOFI - SARCLISA IN COMBINATION WITH POMALIDOMIDE AND DEXAMETHASONE (POM-DEX) SIGNIFICANTLY REDUCED RISK OF DISEASE PROGRESSION OR DEATH IN ADULTS BY 40% COMPARED TO POM-DEX ALONE IN TRIAL

* MOST COMMON ADVERSE REACTIONS IN PATIENTS WHO RECEIVED SARCLISA COMBINATION THERAPY WERE NEUTROPENIA (96%), INFUSION-RELATED REACTIONS (39%), PNEUMONIA (31%), UPPER RESPIRATORY TRACT INFECTION (57%) AND DIARRHEA (26%)

* SERIOUS ADVERSE REACTIONS THAT OCCURRED IN MORE THAN 5% OF PATIENTS WHO RECEIVED SARCLISA COMBINATION THERAPY INCLUDED PNEUMONIA (25.3%) AND FEBRILE NEUTROPENIA (12.3%)

* PERMANENT DISCONTINUATION OF SARCLISA COMBINATION THERAPY DUE TO AN ADVERSE REACTION (GRADES 3-4) OCCURRED IN 7% OF PATIENTS, AND 3% OF PATIENTS DISCONTINUED DUE TO AN INFUSION-RELATED REACTION. Source text for Eikon: Further company coverage: (Reporting By Dominique Vidalon)

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