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The information on this website is based on data from adult patients with ALK-positive advanced NSCLC (anaplastic lymphoma kinase positive advanced non small cell lung cancer) treated with LORVIQUA▼(lorlatinib), produced in line with the LORVIQUA (lorlatinib) Summary of Product Characteristics.
LORVIQUA (lorlatinib) Prescribing Information click here.
▼LORVIQUA is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. Adverse event reporting information can also be found at the bottom of the page.
LORVIQUA was evaluated as a first-line treatment option in the CROWN study. CROWN was a global, randomised, open-label, multicentre, Phase 3 trial of LORVIQUA vs crizotinib in patients with previously untreated, ALK-positive, locally advanced or metastatic NSCLC (N=296).1,2
Crizotinib was selected for the comparator arm because it was the standard-of-care first-line treatment at the time of trial initiation.2
Approximately 26% of patients in both the LORVIQUA and crizotinib treatment arms had brain metastases at baseline.2
Characteristic |
LORVIQUA (n=149) |
Crizotinib (n=147) |
---|---|---|
Age, years | ||
Mean (SD)d | 59.1 (±13.1) | 55.6 (±13.5) |
Median (IQR) | 61 (51-69) | 56 (45-66) |
Sex, n (%) | ||
Female | 84 (56) | 91 (62) |
Male | 65 (44) | 56 (38) |
Race or ethnic group, n (%)e | ||
White | 72 (48) | 72 (49) |
Asian | 65 (44) | 65 (44) |
Black | 0 | 1 (1) |
Missing | 12 (8) | 9 (6) |
Smoking status, n (%)f | ||
Never smoked | 81 (54) | 94 (64) |
Previous smoker | 55 (37) | 43 (29) |
Current smoker | 13 (9) | 9 (6) |
ECOG PS, n (%)g | ||
0 | 67 (45) | 57 (39) |
1 | 79 (53) | 81 (55) |
2 | 3 (2) | 9 (6) |
Characteristic | LORVIQUA (n=149) |
Crizotinib (n=147) |
---|---|---|
Current stage of disease, n (%) | ||
IIIA | 1 (1) | 0 |
IIIB | 12 (8) | 8 (5) |
IV | 135 (91) | 139 (95) |
Otherh | 1 (1) | 0 |
Histologic type, n (%) | ||
Adenocarcinoma | 140 (94) | 140 (95) |
Adenosquamous carcinoma | 6 (4) | 5 (3) |
Large cell carcinoma | 0 | 1 (1) |
Squamous cell carcinoma | 3 (2) | 1 (1) |
Use of previous anticancer drug therapy, n (%)i | ||
12 (8) | 9 (6) | |
Previous brain radiotherapy, n (%) | ||
9 (6) | 10 (7) | |
Brain metastases at baseline, n (%) | ||
38 (26) | 40 (27) |
Pfizer. LORVIQUA (lorlatinib) Summary of Product Characteristics.
Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
Adverse events should also be reported to Pfizer Medical Information on 1800 633 363
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PP-UNP-IRL-0784. June 2024