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
FDA Center
CDER
Application
NDA 216059/S-001
Applicant
Loxo Oncology, Inc.
Product
Jaypirca
Generic Name
pirtobrutinib
Approval Date
December 1, 2023
Document Length
290 pages
File Format
Searchable PDF
Availability
Available for immediate download
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.
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