NDA 216059/S-001 — Jaypirca (pirtobrutinib) FDA Approval Package -- CLL/SLL Supplemental Approval

This FDA approval package contains the agency's complete multidisciplinary review supporting the supplemental approval of Jaypirca (pirtobrutinib) for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The release includes FDA's scientific, clinical, statistical, pharmacology, and regulatory evaluations, documenting how the agency assessed the application and reached its approval decision.

Document Details

Redaction Level

Light redaction (approximately 3%).

Redactions are limited primarily to proprietary commercial information, selected regulatory correspondence, bioanalytical methods, and operational details. FDA's approval rationale, clinical and safety reviews, benefit-risk assessment, inspection findings, labeling decisions, and postmarketing requirements remain substantially readable.

What's Included

• FDA approval letter
• Final prescribing information
• FDA-approved patient information
• Multidisciplinary review
• Benefit-risk assessment
• Clinical efficacy review
• Integrated safety review
• Statistical review
• Clinical pharmacology review
• Population pharmacokinetic analysis
• Exposure-response modeling
• Nonclinical pharmacology and toxicology review
• Clinical inspection summary
• Patient labeling review
• Medication error prevention review
• Postmarketing requirements