LORBRENA

批准信原文要点

This Prior Approval supplemental new drug application provides for updates to DOSAGE AND ADMINISTRATION (Section 2), DRUG INTERACTIONS (Section 7), USE IN SPECIFIC POPULATIONS (Sections 8.6, 8.7), CLINICAL PHARMACOLOGY (Section 12.3), and Patient Information and fulfills postmarketing requirement (PMR) 3500-4.

批准信原文要点

This “Changes Being Effected in 30 days” supplemental new drug application provides for the registration of an additional presentation (120 count in a 60 mL bottle) for the drug product 25 mg strength.

批准信原文要点

The updated indication based on this sNDA has been expanded “for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.”

批准信原文要点

This Prior Approval supplemental new drug application provides for revisions to the following subsections of the LORBRENA (lorlatinib) U.S. Prescribing Information (USPI): • Section 2 DOSAGE AND ADMINISTRATION Subsection 2.6 Dosage Modification for Severe Renal Impairment • Section 8 USE IN SPECIFIC POPULATIONS Subsection 8.7 Renal Impairment • Section 12 CLINICAL PHARMACOLOGY Subsection 12.3 Pharmacokinetics of the Full Prescribing Information (FPI) with corresponding changes to the Patient Package Insert (PPI).

批准信原文要点

This Prior Approval supplemental new drug application provides revisions and additions to the following subsections of the LORBRENA (lorlatinib) U.S. Prescribing Information (USPI), based on data from Study B7461026...

批准信原文要点

This Prior Approval supplemental new drug application provides for revisions to Section 7 DRUG INTERACTIONS Subsection 7.2 Effect of LORBRENA on Other Drugs, and Section 12 CLINICAL PHARMACOLOGY Subsection 12.3 Pharmacokinetics of the Full Prescribing Information (FPI).