The US Food and Drug Administration has expanded pirtobrutinib approval to previously untreated adults with chronic lymphocytic leukemia or small lymphocytic lymphoma and no known 17p deletion. The medicine, sold as Jaypirca, can now be considered at the start of treatment for this population. Its earlier authorization covered disease that returned or resisted treatment after a covalent BTK inhibitor.
The US Food and Drug Administration (FDA), the regulator for medicines, approved pirtobrutinib on October 2 for previously untreated adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The authorization covers patients without a known 17p deletion. It opens first-line use of the medicine for this defined population, expanding the point at which it can be considered during treatment.[1], [2]
CLL and SLL are slow-growing blood cancers affecting lymphocytes, a type of white blood cell. In CLL, cancer cells are mainly in the blood; in SLL, they are mainly in lymph nodes. A 17p deletion is the loss of part of chromosome 17. The new indication specifies that this deletion is not known to be present. Eli Lilly makes pirtobrutinib under the brand name Jaypirca.[1]
Pirtobrutinib's earlier CLL/SLL authorization covered adults whose disease returned or resisted treatment after a covalent BTK inhibitor. Relapsed disease has reappeared after treatment, while refractory disease was not controlled by the previous therapy. BTK, or Bruton tyrosine kinase, is an enzyme involved in several B-cell blood cancers. Pirtobrutinib inhibits this pathway and is taken as an oral tablet.[1]
