The Food and Drug Administration (FDA) has expanded the approval of Lorbrena® (lorlatinib) to include first-line treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

The expanded approval was based on data from the phase 3 CROWN trial (ClinicalTrials.gov: NCT03052608), which included 296 patients with previously untreated advanced ALK-positive NSCLC. Patients were randomly assigned to receive lorlatinib 100mg once daily (n=149) or crizotinib 250mg twice daily (n=147); the primary end point of the study was progression free survival (PFS).

Results showed a significant improvement in PFS for the lorlatinib arm over the crizotinib arm (hazard ratio 0.28; 95% CI, 0.19-0.41; P <.0001). The overall response rate was 76% (95% CI, 68-83) for the lorlatinib group and 58% (95% CI, 49-66) for the crizotinib group. Seventy percent of lorlatinib-treated patients responded to treatment for 12 months or longer compared with 27% of crizotinib-treated patients.

Among patients with measurable intracranial lesions, the intracranial tumor response rate was 82% (95% CI, 57-96) in the lorlatinib arm and 23% (95% CI, 5-54) in the crizotinib arm. The intracranial duration of response was 12 months or longer in 79% of patients in the lorlatinib group and 0% in the crizotinib group.


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Commenting on the approval, Andy Schmeltz, Global President, Pfizer Oncology, said: “Lorbrena has been a transformative medicine for people with ALK-positive advanced NSCLC, and this FDA approval in the first-line setting means that we can now extend hope to even more people.”

Lorbrena is supplied as 25mg and 100mg strength tablets.

References

1.      U.S. FDA expands approval of Pfizer’s Lorbrena® as first-line treatment for ALK-positive metastatic lung cancer. [press release]. New York, US: Pfizer; March 3, 2021.

2.      Lorbrena [prescribing information]. New York, NY; Pfizer. March 2021.