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BRIEF-Takeda announces FDA accelerated approval of ALUNBRIG
April 28, 2017 / 10:29 PM / 8 months ago

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:

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