FDA Grants Accelerated Approval to Brigatinib for Metastatic NSCLC

Guidelines recommend epilepsy drugs soon after first seizure.
Guidelines recommend epilepsy drugs soon after first seizure.
The Food and Drug Administration (FDA) has granted accelerated approval to Alunbrig (brigatinib; ARIAD) tablets.

The Food and Drug Administration (FDA) has granted accelerated approval to Alunbrig (brigatinib; ARIAD) tablets for the treatment of metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in patients who have progressed or are intolerant to crizotinib.

The accelerated approval was based on data from the ALTA trial, a non-comparative, 2-arm, open-label, multicenter clinical trial showing a clinically meaningful and durable overall response rate (ORR) in patients with locally advanced or metastatic ALK-positive NSCLC who progressed on crizotinib. Study patients were randomized to oral brigatinib 90mg daily (n=112) or brigatinib 180mg daily (n=110) after a 7-day lead-in of 90mg daily.

ORR in the 90mg arm was 48% (95% CI: 39%, 58%) and was 53% (95% CI: 43%, 62%) in the 180mg arm. The median duration of responses (DOR) was 13.8 months in both treatment arms.  

Among patients with measurable brain metastases data, intracranial ORR was 42% (95% IC: 23%, 63%) in the 90mg arm and 67% (95% CI: 41%, 87%) in the 180mg arm. The median intracranial DOR was 5.6 months in the 180mg arm; it was not calculable in the 90mg arm. Moreover, 78% and 68% of patients in the 90mg and 180mg arms who had an intracranial response, respectively, maintained this response for ≥4 months. 

The most common adverse events (occurring ≥25%) were nausea, diarrhea, fatigue, cough, and headache. The most common serious adverse events were pneumonia and interstitial lung disease (ILD)/pneumonitis. 

Brigatinib is an investigational oral anaplastic lymphoma kinase (ALK) inhibitor that has activity at clinically achievable concentrations against multiple kinases including ALK, ROS1, insulin-like growth factor-1 receptor (IGF-1R), and FLT-3 as well as EGFR deletion and point mutations. Brigatinib exhibited in vivo anti-tumor activity against four mutant forms of EML4-ALK, including G1202R and L1196M mutants identified in NSCLC tumors in patients who have progressed on crizotinib. 

Alunbrig will be available as 30mg strength tablets in 21- and 180-count bottles and as 90mg strength tablets in 7- and 30-count bottles.


Takeda announces FDA accelerated approval of ALUNBRIG™ (brigatinib) [press release]. Cambridge, MA: Ariad. Published April 28, 2017. Accessed on May 4, 2017.

This article originally appeared on MPR