Posts tagged ALK-positive
ARIAD completes NDA submission for brigatinib

ARIAD Pharmaceuticals (NASDAQ:ARIA) has completed a rolling NDA submission to the FDA for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib.

ARIAD is seeking U.S. marketing approval of brigatinib for patients with metastatic ALK-positive non-small cell lung cancer who are resistant or intolerant to crizotinib.

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ARIAD reports updated data in pivotal ALTA study

ARIAD Pharmaceuticals (NASDAQ:ARIA) has reported updated clinical data for brigatinib, its investigational anaplastic lymphoma kinase (ALK) inhibitor, from the pivotal ALTA trial in patients who had experienced disease progression on crizotinib therapy.

The data show that, of patients on the 180 mg regimen (Arm B) with a median follow-up of 8.3 months, 54% achieved a confirmed objective response, the trial’s primary endpoint. In this arm, the median progression free survival exceeded one year (12.9 months) in this post-crizotinib setting.

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