Reuters logo
BRIEF-Takeda announces FDA accelerated approval of ALUNBRIG
2017年4月28日 / 晚上10点31分 / 7 个月前

BRIEF-Takeda announces FDA accelerated approval of ALUNBRIG

April 28 (Reuters) - Takeda Pharmaceutical Co Ltd:

* Takeda announces FDA accelerated approval of ALUNBRIG(brigatinib)

* Says continued approval for ALK+ metastatic NSCLC indication may be contingent upon verification and description of clinical benefit in a confirmatory trial

* Says serious adverse reactions occurred in 38% of patients in 90 mg group and 40% of patients in 90→180 mg group

* Says fatal adverse reactions occurred in 3.7% of patients

* Says the fatal adverse reactions consisted of pneumonia, sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis and urosepsis

* Says FDA approval of ALUNBRIG was primarily based on results from pivotal phase 2 alta trial of brigatinib in adults Source text for Eikon: 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