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Lilly's Jaypirca Approved for First-Line CLL Therapy
Confirmed
In Short: "Doctors can now consider Jaypirca for appropriate patients when initial therapy is needed, not just later in a patient's treatment journey," said Dr. Woyach.
The FDA has approved pirtobrutinib (Jaypirca, Eli Lilly) for adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion.
Jaypirca, a noncovalent BTK inhibitor, joins covalent BTK inhibitors such as zanubrutinib (Brukinsa) in the first-line market, offering a new option for physicians.
The approval is based on the phase 3 BRUIN CLL-313 trial, where 94% of patients responded to Jaypirca compared to 81% who received chemoimmunotherapy.
Dr. Jennifer A. Woyach, director of the Division of Hematology at The Ohio State University, noted that the approval allows Jaypirca to be used earlier in the treatment course.
"Doctors can now consider Jaypirca for appropriate patients when initial therapy is needed, not just later in a patient's treatment journey," said Dr. Woyach.
The BRUIN CLL-313 trial showed a significant delay in disease progression for Jaypirca compared to chemoimmunotherapy, along with safety and tolerability consistent with its established profile.
"These findings support the potential use of pirtobrutinib in certain treatment-naïve patients and underscore its unique position as the only BTK inhibitor to show promise in treating both newly diagnosed patients with CLL or SLL and those who have progressed on a covalent BTK inhibitor," said Jacob Van Naarden, executive vice president and president, Lilly Oncology.
"The results from BRUIN CLL-313 show a significant effect size, among the most pronounced ever observed for a single agent BTK inhibitor in a front-line CLL study," said Wojciech Jurczak, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland.
"Given the efficacy and tolerability of modern targeted therapies, coupled with factors like age or other health conditions, many people diagnosed with CLL or SLL today may only receive one or two lines of therapy, making initial treatment choices critically important," said Dr. Woyach.
What this adds
Jaypirca previously received traditional US FDA approval in December 2025 for relapsed or refractory CLL/SLL following treatment with a covalent BTK inhibitor.
The new indication moves the drug into a first-line market that already includes covalent BTK inhibitors such as zanubrutinib (Brukinsa), giving physicians a non-covalent BTK option earlier in the treatment pathway.
Complete responses, meaning no remaining signs of cancer were detected, occurred in 13% of patients who received Jaypirca and 21% who received bendamustine plus Rituxan.
Pirtobrutinib was previously approved for CLL/SLL after at least two prior lines of therapy including a Bruton tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.
Background
Lilly's Jaypirca, also known as pirtobrutinib, has been approved as a first-line treatment for chronic lymphocytic leukemia (CLL).
What's confirmed
- "These findings support the potential use of pirtobrutinib in certain treatment-naïve patients and underscore its unique position as the only BTK inhibitor to show promise in treating both newly diagnosed patients with CLL or SLL and those who have progressed on a covalent BTK inhibitor," said Jacob Van Naarden, executive vice president and president, Lilly Oncology.
- Lilly is studying Jaypirca in CLL/SLL in multiple Phase 3 studies.
- The FDA has approved pirtobrutinib (Jaypirca, Eli Lilly) for adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion.
What's still developing
- Complete responses, meaning no remaining signs of cancer were detected, occurred in 13% of patients who received Jaypirca and 21% who received bendamustine plus Rituxan.
- Jaypirca is a pill that blocks Bruton tyrosine kinase (BTK), a protein involved in the growth and survival of certain cancerous B cells.
- After a median follow-up of 28 months, Jaypirca significantly reduced the risk of disease progression or death compared with bendamustine plus Rituxan.
- "The magnitude of the progression-free survival benefit, early overall survival trend and safety profile observed in BRUIN CLL-313 offer highly compelling evidence for the potential role of pirtobrutinib in treatment-naïve CLL."
- "Alongside the recently presented BRUIN-CLL 314 results, we are excited about how collectively these data may advance the therapeutic landscape in treatment-naïve CLL and are hopeful we will receive regulatory approvals for pirtobrutinib in earlier disease settings sometime next year, further expanding treatment options for patients."
- Still, Lilly says pirtobrutinib has an advantage over its covalent BTK rivals: As a noncovalent inhibitor, its reversible binding allows it to retain activity against BTK mutations that can drive resistance to acalabrutinib, zanubrutinib, and ibrutinib.
- BR was a common first-line option when the trial was launched but has since been largely replaced by targeted approaches, including BTK inhibitors and venetoclax -based regimens.
- Neutropenia was the most common grade 3 or 4 lab abnormality.