LORBRENA (lorlatinib) 1 Health Professional Information

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1 INDICATIONS

LORBRENA (lorlatinib) is indicated as:

  • monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC)

  • monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive metastatic non-small cell lung cancer (NSCLC) who have progressed on: crizotinib and at least one other ALK inhibitor, or patients who have progressed on ceritinib or alectinib.

    The marketing authorization with conditions was based on a primary efficacy endpoint of tumor objective response rate and duration of response; no overall survival benefit has been demonstrated (see 14 CLINICAL TRIALS).

1.1 Pediatrics

Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

1.2 Geriatrics

Geriatrics (≥ 65 years of age): Of the patients in Study B7461001 (N=295) and Study B7461006 (N=149) who received 100 mg LORBRENA orally once daily, 54 (18%) and 59 (40%), respectively, were aged 65 years or older. No clinically important differences in safety or efficacy were observed between patients aged 65 years or older and younger patients (see 10 CLINICAL PHARMACOLOGY).