LORVIQUA® Authorized as First-Line Treatment in European Union
Precision medicine has transformed cancer care in recent decades, often enabling doctors to pinpoint and then precisely target the sub-cellular abnormality from which the cancer sprung. Even so, by the time cancer has spread to the brain, it is often difficult to treat.
That’s because of the blood-brain barrier, which evolved to block pathogens and toxins from entering the brain and can also prevent the passage of beneficial medications. LORVIQUA® (lorlatinib), available in the U.S. under the brand name LORBRENA®, is a third-generation medicine developed by Pfizer to treat advanced non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive. The drug was designed to specifically break through the blood-brain barrier.1
Approximately 25 to 40% of patients with ALK+ NSCLC either have brain metastases - cancer that has spread to the brain, at baseline, or develop brain metastases within two years of diagnosis.2
Now, adults with advanced ALK+ NSCLC living in the European Union (EU) have access to LORVIQUA monotherapy as a first- line treatment under a marketing authorization granted by the European Commission in January 2022. Previously, LORVIQUA was available in the EU only under a conditional marketing authorization and only to a subset of patients with advanced ALK+ NSCLC whose cancer progressed after earlier ALK- targeting therapies.
LORVIQUA attacks the cancer at its source by tamping down the activity of the ALK protein, which is altered in ALK+ NSCLC, causing runaway cell growth.³
In the pivotal Phase 3 head-to-head CROWN clinical trial, ALK+ NSCLC patients who received LORVIQUA had 72% lower risk of progression or death than those who received XALKORI® (crizotinib).4 Importantly, 82% of participants with brain metastases that could be measured saw their brain tumors shrink or disappear entirely following LORVIQUA treatment, compared to 23% for XALKORI, which also works by targeting ALK protein but with less brain penetration.5 Out of 112 patients who did not have brain metastases when enrolled in the trial who were treated with LORVIQUA, only one developed brain metastases.
XALKORI is another Pfizer product and was authorized in the EU as a first-line treatment for ALK+ NSCLC in 2015. But we didn’t stop there. We kept pushing the envelope.
And now, in 2022, the success of LORVIQUA is a testament to our culture of never settling. At Pfizer, we continue to work tirelessly to help address unmet needs for people living with advanced, biomarker-driven lung cancers.
- Akamine T, Toyokawa G, Tagawa T, Seto T. Spotlight on lorlatinib and its potential in the treatment of NSCLC: the evidence to date. Onco Targets Ther. 2018 Aug 22;11:5093-5101. doi: 10.2147/OTT.S165511. PMID: 30174447; PMCID: PMC6110295.
- Abdallah SM, Wong A. Brain metastases in non-small-cell lung cancer: are tyrosine kinase inhibitors and checkpoint inhibitors now viable options? Curr Oncol. 2018 Jun;25(Suppl 1):S103-S114. doi: 10.3747/co.25.3733. Epub 2018 Jun 13. PMID: 29910653; PMCID: PMC6001769.
- Du X, Shao Y, Qin HF, Tai YH, Gao HJ. ALK-rearrangement in non-small-cell lung cancer (NSCLC). Thorac Cancer. 2018 Apr;9(4):423-430. doi: 10.1111/1759-7714.12613. Epub 2018 Feb 28. PMID: 29488330; PMCID: PMC5879058.
- Shaw AT, Bauer TM, de Marinis F, et al. First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer. N Engl J Med. 2020;383(21):2018-2029. doi:10.1056/NEJMoa2027187
- Bauer TM, Shaw AT, Johnson ML, et al. Brain Penetration of Lorlatinib: Cumulative Incidences of CNS and Non-CNS Progression with Lorlatinib in Patients with Previously Treated ALK- Positive Non-Small-Cell Lung Cancer. Target Oncol. 2020 Feb;15(1):55-65. doi: 10.1007/s11523-020-00702-4. PMID: 32060867; PMCID: PMC7028836.
