The US Food and Drug Administration (FDA) has approved pirtobrutinib for adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion.
CLL/SLL are rare cancers that affect B lymphocytes. The conditions are similar in pathophysiology but differ primarily in location of the disease. In patients with CLL, the cancer mainly manifests in the bloodstream, while in patients with SLL, it is in the lymph nodes and lymphoid tissue. CLL accounts for the majority (90%) of cases. Early signs and symptoms may include swollen lymph nodes, fatigue, weight loss, fever, night sweats and/or frequent infections. The underlying cause is thought to be a combination of genetic and other unknown factors.
The FDA approval is largely based on results from the BRUIN CLL-313 (NCT05023980), a randomized, open-label, active-controlled trial in 282 patients with previously untreated CLL/SLL without deletion of chromosome 17p.
With an estimated median follow-up for progression-free survival (PFS) of 28 months, the median PFS was not estimable in the pirtobrutinib arm and 33.5 months in the bendamustine and rituximab arm. At the time of the primary PFS analysis, overall survival (OS) data was immature. The median OS was not reached in either arm with a total of 13 deaths, three in the pirtobrutinib arm and 10 deaths in the control arm.
The most common non-laboratory adverse reactions occurring in patients receiving pirtobrutinib were upper respiratory tract infections, rash, and COVID-19. The most common Grade 3 or 4 laboratory abnormality was neutrophil count decreased. Serious adverse reactions occurred in 28% of patients taking pirtobrutinib.
The prescribing information for pirtobrutinib includes warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, secondary primary malignancies, hepatotoxicity, and embryo-fetal toxicity.
For more information, visit https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pirtobrutinib-previously-untreated-chronic-lymphocytic-leukemia-or-small-lymphocytic
To learn more about CLL/SLL and other rare cancers, visit https://checkrare.com/diseases/cancers/