In January 2023, the U.S. FDA approved Jaypirca (pirtobrutinib) for the treatment of adults with relapsed or refractory mantle cell lymphoma who had previously undergone two lines of systemic therapy, including a BTK inhibitor. Researchers explored whether Jaypirca would be effective for other forms of blood cancer. Following a recent study, reported by Jonathan Gardner in Biopharma Dive, the FDA granted conditional approval to Jaypirca as a treatment for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who had previously received at least two lines of therapy, including a BTK inhibitor and BCL-2 inhibitor.
The expanded approval comes after a Phase 3 clinical study with 108 participants. Prior to the study, participants had received a median of 5 lines of treatment. The study found that Jaypirca led to a sustained response for a period of 1 year or longer. Additionally, 72% of participants experienced the disappearance or slowing down of signs and symptoms of their cancer.
Another confirmatory trial demonstrated that Jaypirca halted disease progression in people with CLL or SLL who were BTK inhibitor treatment-naive. More data will be available next year after undergoing formal review.
CLL: The Facts to Know
Chronic lymphocytic leukemia is a blood cancer that originates in the bone marrow, the spongy tissue inside your bones where blood cells form. In CLL, the bone marrow produces abnormal lymphocytes, a type of white blood cell. As these cells proliferate, they displace healthy blood cells from the bone marrow. CLL may progress quickly or slowly depending on its form. The exact cause of CLL is unknown, but doctors have identified risk factors, including older age, being Caucasian, having a family history of CLL, or exposure to chemicals like Agent Orange. In early stages, people with CLL may show no signs or symptoms. Symptoms usually manifest as the cancer progresses and may include unexplained weight loss, drenching night sweats, an enlarged spleen, upper left abdominal pain, fever, fatigue, swollen lymph nodes, easy bruising and bleeding, petechiae, general weakness, and recurrent infections.
If you have chronic lymphocytic leukemia, your doctor may recommend different treatment options, such as chemotherapy, targeted therapies like Zydelig or Revlimid, or a stem cell transplant. Please consult with your care team to identify the best line of treatment for you.
