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Brigatinib is an ALK pill with strong brain activity, approved first after crizotinib and then first line after beating it in ALTA-1L.
Brigatinib is a second-generation ALK inhibitor with broad activity against resistance mutations including G1202R, and at higher doses it also inhibits wild-type EGFR; it penetrates the brain well. The ALTA trial (2017) established activity after crizotinib, and ALTA-1L (2018 to 2020) showed first-line superiority over crizotinib with median progression-free survival of 24 versus 11 months and a 78% intracranial response rate. It was approved in the US in 2017 after crizotinib and in 2020 first line, and in the EU in 2018. Early pulmonary events in the first week are its distinctive toxicity, which is why treatment starts with a 90 mg lead-in dose before escalation. It competes with alectinib and lorlatinib in the first line, and no trial has directly compared them. Brigatinib is an ALK pill whose main strengths are brain activity and coverage of resistance mutations.
Broad-spectrum ALK inhibitor with activity against G1202R and other resistance mutations plus wild-type EGFR at higher doses. Connects to ALK.
1.Brigatinib slips into a pocket on ALK.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA670 · SMC advice: brigatinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Patients with ALK-positive metastatic NSCLC that have progressed or are intolerant to crizotinib
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Patients with ALK-positive metastatic NSCLC that have progressed or are intolerant to crizotinib
Confirmed: the accelerated approval of 2017 converted to traditional approval 3.1 years after it was granted.
| Region | Year | Indication |
|---|---|---|
| US | 2017 | ALK-positive metastatic NSCLC after crizotinib |
| US | 2020 | First-line ALK-positive metastatic NSCLC |
| EU | 2018 | ALK-positive NSCLC |
| England (NICE) | 2019 | ALK-positive advanced non-small-cell lung cancer after crizotinib · TA571, published 20 March 2019, subject to the commercial arrangement. |
| England (NICE) | 2021 | ALK-positive advanced non-small-cell lung cancer not previously treated with an ALK inhibitor · TA670, published 27 January 2021 (ALTA-1L), subject to the commercial arrangement. |
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Brigatinib is the first drug shown to act across the tumour types of NF2-related schwannomatosis and is now offered for progressive tumours; the platform design lets further drugs be tested against the same benchmark.
This is the trial behind brigatinib's first approval, after crizotinib, and it set the 180 mg dose with a 90 mg lead-in that the label uses. For a patient it shows a drug with strong activity in the brain and an unusual early lung side effect that the lead-in week was designed to soften.
It made repeat biopsy and genotyping at progression the standard in ALK-positive lung cancer, because after a second-generation inhibitor the presence or absence of an ALK mutation is what separates patients who should receive a third-generation inhibitor from those who should not.
Query for this drug: (TITLE:"Brigatinib" OR ABSTRACT:"Brigatinib" OR TITLE:"Alunbrig" OR ABSTRACT:"Alunbrig") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Brigatinib, not a curated reading list.
Shares Using Tumor Models to Determine Treatments, Molecular mechanisms of resistance to first- and second-generation ALK inhibitors in ALK-rearranged lung cancer, ALK fusion (ALK-positive), Lung cancer drugs in England: what NICE has recommended.
Shares Brigatinib in patients with crizotinib-refractory ALK-positive non-small-cell lung cancer: a randomized, multicenter phase II trial (ALTA), ALTA, ALTA-1L, ALK-positive non-small-cell lung cancer.
Shares Brigatinib in patients with crizotinib-refractory ALK-positive non-small-cell lung cancer: a randomized, multicenter phase II trial (ALTA), ALTA, ALK, Non-small-cell lung cancer.
Shares ALK fusion (ALK-positive), Non-small cell lung cancer (KEGG map), ALK-positive non-small-cell lung cancer, ALK.
Shares Molecular mechanisms of resistance to first- and second-generation ALK inhibitors in ALK-rearranged lung cancer, ALK fusion (ALK-positive), ALK, Small-molecule kinase inhibitors.
Shares Molecular mechanisms of resistance to first- and second-generation ALK inhibitors in ALK-rearranged lung cancer, ALK-positive non-small-cell lung cancer, ALK, Non-small-cell lung cancer.
Shares ALK fusion (ALK-positive), ALK-positive non-small-cell lung cancer, ALK, Small-molecule kinase inhibitors.
Shares ALTA-1L, ALK-positive non-small-cell lung cancer, ALK, Lung cancer (all types).