FDA clears Lilly's Jaypirca pill as a first leukemia treatment
The FDA has cleared a Lilly pill called Jaypirca as a first treatment for CLL. CLL is the most common leukemia in adults. In a trial of 282 patients, the daily pill cut the risk of the cancer getting worse, or of death, by about 80% compared with chemo.
The Food and Drug Administration has approved a daily pill from Eli Lilly as a first treatment for chronic lymphocytic leukemia, or CLL, the most common leukemia in adults. The drug, Jaypirca, also known as pirtobrutinib, was cleared on October 2.
The approval covers adults who have not been treated before and whose cancer does not have a gene change called a 17p deletion. It also covers small lymphocytic lymphoma, a closely related cancer.
Until now, Jaypirca was used only after other drugs had stopped working. Moving it to the front of the line gives patients and doctors one more first choice.
The decision rests on a trial of 282 patients. Half took Jaypirca once a day. The other half got six rounds of an older mix of chemotherapy and an antibody drug. After about 28 months, the pill lowered the risk of the cancer getting worse or the patient dying by about 80%, Hematology Advisor reported. Three patients died in the Jaypirca group, compared with 10 in the other group, the FDA said.
The most common side effects were colds and other upper airway infections, rash and COVID-19. About 28% of patients had serious side effects. The label warns about infections, bleeding, heart rhythm problems and liver damage.
Jaypirca joins three older drugs of the same type, Imbruvica, Calquence and Brukinsa, as first-line options, Medscape reported. Those drugs latch onto their target for good. Jaypirca grips it more loosely, and Lilly says that lets it keep working against some mutations that make the older drugs fail.
One critique: the chemotherapy used in the trial has mostly been replaced by newer targeted drugs, Medscape noted, so the trial did not compare Jaypirca with today's most common care.
Patients with CLL should talk with their cancer doctor about whether the change fits their case.
What we know: Jaypirca is now approved as a first treatment for many CLL patients.
What we don't: Whether it lengthens life, since survival data are not yet mature.
Where outlets agree Medscape and Hematology Advisor both report that the 282-patient trial found three deaths on Jaypirca and 10 on chemotherapy.
Where they differ Medscape says Jaypirca was previously approved only after both a BTK inhibitor and a BCL-2 inhibitor, while Hematology Advisor says it was approved after a covalent BTK inhibitor.