What Is Jaypirca and Why Does It Matter?
The FDA has approved Jaypirca (pirtobrutinib) for adults with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This approval is for patients whose cancer cells do not have a specific gene change called a 17p deletion. CLL and SLL are slow-growing blood cancers that affect white blood cells called lymphocytes. These cells help your body fight infections, but cancer causes them to grow out of control.
Jaypirca is a pill you take by mouth. It works by blocking a specific protein in B-cells called BTK. Cancer cells need this protein to grow, spread, and survive. By blocking this protein, Jaypirca helps slow or stop cancer growth.
Jaypirca was already approved for CLL or SLL in patients who were previously treated with a different BTK inhibitor. This expanded approval gives healthcare providers a new option for adults who need initial treatment for CLL or SLL. Unlike some other therapies, Jaypirca can be taken once daily at home. It provides another choice for managing these lifelong conditions early in the disease.
Why Was Jaypirca Approved?
The FDA approved Jaypirca based on results from a large study called BRUIN CLL-313. The study included 282 adults with untreated CLL or SLL without a 17p deletion. Half of the patients took Jaypirca once daily. The other half received standard chemoimmunotherapy using bendamustine and rituximab for up to six cycles.
The main goal of the study was to see how long patients lived without their cancer growing or getting worse. Patients taking Jaypirca lived significantly longer without their disease progressing than those who received chemoimmunotherapy. At two years, 93.4% of patients in the Jaypirca group were alive without their cancer growing, compared to 70.7% of patients in the chemoimmunotherapy group.
Jaypirca was also better tolerated than the standard treatment. Severe side effects occurred in 40% of patients taking Jaypirca compared to 67.4% of patients taking chemoimmunotherapy. Fewer people stopped treatment because of side effects in the Jaypirca group (4.3%) than in the chemoimmunotherapy group (15.2%).
What Do I Need to Know?
Jaypirca is taken as a tablet by mouth once daily. You can take it with or without food, but you should swallow the tablets whole with water. Do not cut, crush, or chew the tablets. Try to take your dose at the same time every day.
Jaypirca can cause serious side effects, including severe infections, bleeding problems, low blood cell counts, and heart rhythm problems. It can also increase the risk of getting other cancers, such as skin cancer. You should protect your skin from sun exposure while taking this medicine. Contact your healthcare provider immediately if you notice signs of infection (such as a fever or chills), unusual bleeding or bruising, severe fatigue, or an irregular heartbeat.
Tell your healthcare provider about all medicines, vitamins, and supplements you take before starting Jaypirca. Certain drugs can change how Jaypirca works in your body, and your dose may need to be adjusted. You should also tell your healthcare provider if you have liver or kidney problems or if you plan to have surgery; you may need to stop taking Jaypirca temporarily before your procedure.
If you are pregnant or plan to become pregnant, talk to your healthcare provider. Jaypirca can cause harm to a fetus. If you can become pregnant, you should use effective birth control during treatment and for one week after the last dose. You should not breastfeed while taking Jaypirca and for one week after your last dose.