From WebMD · · 1m 40s
FDA approves Jaypirca for untreated blood cancers
The drug pirtobrutinib gains approval for first-time treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma in patients without a 17p deletion.
In brief
The drug pirtobrutinib gains approval for first-time treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma in patients without a 17p deletion. The FDA approved Jaypirca for adults with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma without a 17p deletion, expanding its use…
FDA approves Jaypirca for blood cancers
The FDA has approved Jaypirca (pirtobrutinib) for adults with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma without a 17p deletion. CLL and SLL are slow-growing blood cancers affecting white blood cells.
How Jaypirca works
Jaypirca is a pill taken by mouth once daily.It works by blocking BTK, a specific protein in B-cells that cancer cells need to grow, spread, and survive.Blocking this protein helps slow or stop cancer growth.
Study shows Jaypirca outperforms standard treatment
The FDA approval was based on the BRUIN CLL-313 study of 282 adults with untreated CLL or SLL. At two years, 93.4% of Jaypirca patients were alive without disease progression, compared to 70.7% receiving chemoimmunotherapy.
Jaypirca better tolerated than standard therapy
Severe side effects occurred in 40% of Jaypirca patients versus 67.4% receiving chemoimmunotherapy. Only 4.3% of Jaypirca patients stopped treatment due to side effects, compared to 15.2% in the chemoimmunotherapy group.
Serious side effects and precautions
Jaypirca can cause severe infections, bleeding problems, low blood cell counts, heart rhythm problems, and increased risk of other cancers including skin cancer.
Pregnancy and drug interactions require caution
Jaypirca can harm a fetus.Patients who can become pregnant must use effective birth control during treatment and for one week after the last dose.
At a glance
The FDA approved Jaypirca for adults with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma without a 17p deletion, expanding its use beyond previously treated patients.
