Eli Lilly and Company received Accelerated Approval from the U.S. Food and Drug Administration (FDA) on Jan. 27, 2023, for Jaypirca^™ (pirtobrutinib) tablets. It is a Bruton’s tyrosine kinase (BTK) inhibitor indicated for treating adult patients who have relapsed or refractory mantle cell lymphoma (r/rMCL) that has been treated twice or more, including with another BTK inhibitor. Although other BTK inhibitors are available in the U.S. for treating MCL, Jaypirca is the first one that is not covalent, meaning it blocks BTK in different ways than other drugs in the class. Therefore, it can be used after another BTK inhibitor has stopped working. Its recommended dose is 200mg once every day. No exact launch date has been released, but its introduction is planned for the next few weeks. The wholesale acquisition cost (WAC) is set at $21,000 per month. Accredo is included in the large network of specialty pharmacies that will dispense Jaypirca. Look for its prescribing information here.

At a Glance

• Brand (Generic) Name: Jaypirca (pirtobrutinib) tablets
• Manufacturer: Eli Lilly and Company
• Date Approved: Jan. 27, 2023
• Indication: to treat adults who have r/rMCL that has been treated with two or more lines of drug therapy including with another BTK inhibitor
• Dosage Forms Available: 50mg and 100mg tablets
• Launch Date: in the “coming weeks”
• Estimated Annual Cost: approximately $252,000
• MCL is an uncommon type of non-Hodgkin lymphoma (NHL) accounting for around 5% of the 80,000 or so new cases of NHL in the U.S. each year. Typically diagnosed in older adults, MCL impacts more men than women.
• Usually fairly fast-growing, MCL eventually extends outside of the lymphatic system where it can attack bone marrow and internal organs, such as the intestines, liver, and stomach.
• Jaypirca decreases the production of cancerous B cells by adhering to BTK and reducing its activity in ways that are not the same as those of other drugs in the BTK inhibitor therapy class.
• In the phase I/II BRUIN clinical study, 50% of the 120 patients treated with Jaypirca had some response, which lasted an average of 8.3 months.
• Patients taking Jaypirca should be alert for signs of atrial arrhythmias, infections, and unusual bleeding. Complete blood counts should be done periodically during treatment because using Jaypirca may decrease the formation of red blood cells and/or white blood cells. Some patients may have secondary cancers, particularly skin cancers. Since unborn babies may be injured, women who may become pregnant during treatment with Jaypirca should use reliable forms of contraception until at least one month after therapy ends.
• Several regimens of chemotherapy (chemo) – most also including the monoclonal antibody rituximab – are used to treat MCL. Resistance to treatment develops often, however, and many patients need other kinds of drug therapy. Some patients qualify for stem cell transplants.
• Other BTK inhibitors, Brukinsa^® (zanubrutinib – BeiGene) capsules, Calquence (acalabrutinib – AstraZeneca) tablets, and Imbruvica® (ibrutinib – Pharmacyclics) capsules/tablets/oral suspension, have FDA’s Accelerated Approvals as second-line or later treatment for r/rMCL. Because they all work in similar ways, when one of them fails, neither of the other two is likely to be effective for the patient. Jaypirca can be used, though, due to its different methods of binding to BTK.
• Because Accelerated Approval was granted for Jaypirca, positive results from advanced clinical trials are required before the FDA awards full approval.