Eli Lilly and Co. (LLY) announced that the FDA has expanded cancer med Jaypirca's approval to include treatment for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent Bruton tyrosine kinase (BTK) inhibitor.
This FDA decision not only allows Jaypirca to be used earlier in treatment but also changes its December 2023 accelerated approval for later-stage CLL/SLL into a full, traditional approval.
The drug was approved for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor, in December 2023, under the FDA's Accelerated Approval pathway.
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are forms of slow-growing non-Hodgkin lymphoma that develop from white blood cells known as lymphocytes. When the cancer primarily forms in the blood and bone marrow, it is referred to as CLL, and when it mainly arises in the lymph nodes, it is known as SLL.
Jaypirca received its initial FDA approval in January 2023 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor, under the FDA's Accelerated Approval pathway.
The drug recorded $337 million in revenue for the full year of 2024 and generated $358 million in sales for the nine months ended September 30, 2025.
LLY closed Wednesday's trading at $1,033.56, down 1.20%.
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