Lorlatinib
An ALK inhibitor with the longest disease control ever recorded for a targeted lung cancer pill: 60% progression-free at five years.
CROWN: 5-year PFS 60% versus 8% for crizotinib; near-complete CNS protection. Neurocognitive and lipid side effects need management.
1.Oral drug is absorbed and reaches the tumour
- Route
- Oral
- Schedule
- 100 mg once daily
- Dose modifications
- Reduce to 75 then 50 mg for CNS effects, hyperlipidaemia, AV block
- Monitoring
- Lipids at baseline and monthly; ECG; mood and cognition; LFTs
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
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).
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Pfizer Oncology Together
- Pfizer RxPathways
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Appraised for
- ALK-positive NSCLC after alectinib, ceritinib or crizotinib then another TKI
- Notes
- Untreated ALK-positive NSCLC (CROWN) appraised 2022 and recommended.
- Cancer Drugs Fund
- Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA628 · NHS England Cancer Drugs Fund list · SMC advice: lorlatinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 2 Nov 2018ApprovalUS
ALK+ NSCLC after prior ALK TKIs (accelerated) source
- 3 Mar 2021ApprovalUS
First-line ALK+ NSCLC (CROWN); full approval source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2018 | ALK+ NSCLC after prior ALK TKI |
| US | 2021 | First-line ALK+ NSCLC |
| Adverse event |
|---|
| Hypercholesterolaemia |
| Hypertriglyceridaemia |
| Oedema |
| Weight gain |
| Peripheral neuropathy |
| Cognitive and mood effects |
| Hypertension |
CROWN: ~70% any grade, ~20% grade 3-4. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | pfizeroncologytogether.com |
| United Kingdom | NICE: recommended first-line for ALK+ NSCLC (TA909) | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Lorlatinib" OR ABSTRACT:"Lorlatinib" OR TITLE:"Lorbrena" OR ABSTRACT:"Lorbrena") 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 Lorlatinib, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductAlectinib
Shares Neladalkib, Prevention trials aimed only at brain metastasis, The blood–brain barrier & brain metastasis, ALK.
- ProductCrizotinib
Shares University of Colorado Cancer Center, Children's Hospital of Philadelphia, ALK, Pfizer (incl. Seagen).
- TargetROS1
Shares Dong-Wan Kim, University of Colorado Cancer Center, Sequence: targeted therapy before immunotherapy in driver-positive NSCLC, Receptor tyrosine kinase activation.
- ProductOsimertinib
Shares Myung-Ju Ahn, Brain metastases included by default in every solid-tumour trial, Sequence: targeted therapy before immunotherapy in driver-positive NSCLC, Prevention trials aimed only at brain metastasis.
- ProductTucatinib
Shares Brain metastases included by default in every solid-tumour trial, Prevention trials aimed only at brain metastasis, Organ tropism: seed and soil, The blood–brain barrier & brain metastasis.
- TargetRET
Shares Justin F. Gainor, Sequence: targeted therapy before immunotherapy in driver-positive NSCLC, Shanghai Chest Hospital, Receptor tyrosine kinase activation.
- ProductEntrectinib
Shares University of Colorado Cancer Center, ALK, Receptor tyrosine kinase activation, Small-molecule kinase inhibitors.
- TrialALKOVE-1
Shares Neladalkib, ALK, Non-small-cell lung cancer.