The U.S. Food and Drug Administration has approved a treatment from Indianapolis-based Eli Lilly and Co. for adult patients with relapsed or refractory mantle cell lymphoma, or MCL. Jaypirca was approved Friday for the use under the FDA’s Accelerated Approval pathway based on results from a Phase 1/2 study.
MCL is a rare blood cancer that starts in white blood cells in the lymph nodes for which there is no cure, according to Lilly. The disease affects about 1 in 200,000 people worldwide each year.
Loxo@Lilly, the oncology unit of Eli Lilly, said the treatment is for patients who have received at least two lines of systemic therapy, including a Bruton’s tyrosine kinase, or BTK, inhibitor. The company said Jaypirca can reestablish BTK inhibition in MCL patients to help put the disease in remission.
The wholesale cost of the treatment, Jaypirca, will be $21,000 per 30 days for the 200 mg dose, the drugmaker told Reuters.
Dr. Michael Wang, the Puddin Clarke Endowed Professor of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, said in a press release from Lilly that the approval is an important advance for patients who have limited options and have a poor prognosis following discontinuation of treatment.
Lilly expects to make Jaypirca available in the United States in the coming weeks.
“Until now, people living with MCL who can no longer be treated with BTK inhibitors have had few alternatives,” said Meghan Gutierrez, CEO of the Lymphoma Research Foundation, in written comments. “The approval of Jaypirca brings a new treatment option and, along with that, new hope for people with relapsed or refractory MCL.”
Because of the accelerated approval, Lilly said continued approval for the treatment may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Lilly received the rights to Jaypirca, formerly known as Loxo-305, when it acquired Loxo Oncology for $8 billion in 2019. Loxo also developed Retevmo, or selpercatinib, which generated sales for Lilly of about $87 million in the first half of 2022.