Food and Drug Administration (FDA) has recently approved brigatinib against anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) in adult patients.
The effectiveness of brigatinib was evaluated in ALTA 1L study. It was an open-label, randomized, multicenter trial with advanced ALK-positive NSCLC patients who had not received ALK-targeted therapy earlier. It required patients to have an ALK rearrangement attributed to a local standard of care testing.
A total of 275 patients were included and randomized to receive either brigatinib or its active comparator, crizotinib. Among 275 patients, 137 patients received 90 mg brigatinib orally once daily for 7 days, followed by 180 mg once daily continuously until disease progression, withdrawal of consent, unacceptable toxicity or death. The remaining 138 patients received 250 mg crizotinib orally two times a day daily until the same conditions in the first group.
The primary outcome measured during the study was progression-free survival (PFS) and the secondary outcome was objective rate response (ORR). The estimated median PFS was estimated to be 11 months for patients treated with crizotinib and 24 months for those treated with brigatinib. Further, the confirmed ORR for patients treated with crizotinib and brigatinib was 62% and 74%, respectively.
Most common side effects noticed with the treatment of brigatinib were rash, cough, nausea, fatigue, diarrhea, dyspnea, headache, vomiting, myalgia and hypertension.
These findings support the use of brigatinib for the management of ALK-positive NSCLC. It can effectively treat ALK-positive NSCLC while prolonging survival rates.
| Source | FDA |
| Link | https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brigatinib-alk-positive-metastatic-nsclc |
| Original title of the article | FDA approves brigatinib for ALK-positive metastatic NSCLC |
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