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The oncology division of Eli Lilly (NYSE:LLY) announced Friday that the FDA greenlighted its Bruton’s tyrosine kinase (BTK) inhibitor Jaypirca as a late-line option for certain patients with mantle cell lymphoma (MCL), a rare blood cancer.
The FDA has granted accelerated approval for Jaypirca, meaning the company is required to prove its clinical benefit in a confirmatory trial for continued approval.
According to labeling information, Jaypirca, also known as pirtobrutinib, is indicated for adults with relapsed or refractory MCL who have at least received two lines of systemic therapy, including a BTK inhibitor.
The FDA decision is based on data from a subset of patients who took part in the company’s BRUIN Phase 1/2 trial. The single-arm study indicated an overall response rate of 50%, including a 13% of complete response for patients who received Jaypirca.
“Until now, people living with MCL who can no longer be treated with BTK inhibitors have had few alternatives,” remarked Meghan Gutierrez, Chief Executive of the Lymphoma Research Foundation.
“The approval of Jaypirca brings a new treatment option and, along with that, new hope for people with relapsed or refractory MCL.” The company expects to launch Jaypirca in the coming weeks.
Read: Seeking Alpha contributor Acutel details the reasons for investor optimism on Lilly’s (LLY) “future despite the high valuation.”
