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FDA Grants Accelerated Approval to Pirtobrutinib for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

by MedOncMD on December 18, 2023

Empowering Hope: A Breakthrough in CLL/SLL Treatment

On December 1, 2023, the Food and Drug Administration (FDA) delivered a beacon of hope by granting accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company). This approval is a significant stride in the treatment landscape for adults facing chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have traversed at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

The BRUIN Trial: Unveiling Promising Results

The efficacy of pirtobrutinib was evaluated in the BRUIN trial (NCT03740529), a global, open-label study encompassing 108 patients with CLL or SLL, all of whom had previously undergone at least two lines of therapy, inclusive of a BTK inhibitor and a BCL-2 inhibitor. With a median of 5 prior lines of therapy, the trial showcased the resilience of patients in their journey. Notably, 77% of participants discontinued the last BTK inhibitor due to refractory or progressive disease.

Key Efficacy Outcomes

The primary efficacy measures, overall response rate (ORR) and duration of response (DOR), were assessed by an independent review committee using the 2018 iwCLL criteria. Pirtobrutinib demonstrated an impressive ORR of 72%, with a median DOR reaching 12.2 months. It’s important to note that all responses observed were partial responses.

Safety Profile: Navigating Adverse Reactions

Patients on pirtobrutinib reported common adverse reactions, including fatigue, bruising, cough, musculoskeletal pain, and COVID-19, among others. Serious infections occurred in 32% of patients, with fatal infections reported in 10%. The prescribing information emphasizes warnings and precautions related to infections, hemorrhage, cytopenias, cardiac arrhythmias, and secondary primary malignancies.

Dosage and Recommendations

Healthcare providers are recommended to administer pirtobrutinib at a dose of 200 mg orally once daily until disease progression or unacceptable toxicity. Notably, this application was granted priority review and orphan drug designation, reflecting the urgency and significance of the treatment.

Reporting Adverse Events and Seeking Assistance

Healthcare professionals are encouraged to report any serious adverse events linked to pirtobrutinib through the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient Investigational New Drug (IND) requests for oncology products, healthcare professionals can reach out to OCE’s Project Facilitate at 240-402-0004 or via email at OncProjectFacilitate@fda.hhs.gov.

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About the author

Dr. Daniel Landau, a distinguished board-certified hematologist/oncologist, has built a commendable career spanning two eminent institutions: the Orlando Health Cancer Institute and the Medical University of South Carolina

Dr. Daniel Landau is a distinguished board-certified hematologist/oncologist renowned for his exceptional contributions in the field. With an illustrious career spanning across esteemed institutions like the Orlando Health Cancer Institute and the Medical University of South Carolina, Dr. Landau’s expertise shines in both genitourinary oncology and hematology.

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