Lilly gets Jaypirca FDA approval for mantle cell lymphoma

Loxo@Lilly, the oncology division of Eli Lilly and Company (Lilly), has secured the accelerated approval of the US Food and Drug Administration (FDA) for Jaypirca (pirtobrutinib) for the treatment of mantle cell lymphoma (MCL).

To be available in 100mg and 50mg tablets, Jaypirca is specifically indicated for the treatment of adult patients having relapsed or refractory mantle cell lymphoma who were subject to at least a couple of lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

Jaypirca FDA approval was backed by the findings of the BRUIN phase 1/2 trial where 120 patients with mantle cell lymphoma treated with Jaypirca 200mg once daily achieved an overall response rate of 50% while 13% patients achieved a complete response.

Michael Wang — The University of Texas MD Anderson Cancer Center Lymphoma and Myeloma department Puddin Clarke Endowed Professor, said: “These data indicate that Jaypirca can provide efficacy in patients previously treated with a covalent BTK inhibitor, potentially extending the time patients may benefit from BTK inhibition therapy.

“Jaypirca offers a new approach to targeting the BTK pathway following treatment with a covalent BTK inhibitor and has the potential to meaningfully impact the treatment paradigm for relapsed and refractory MCL patients.”

Lilly secures Jaypirca FDA approval for mantle cell lymphoma. Photo courtesy of Momoneymoproblemz/Wikipedia.org.

The continued Jaypirca FDA approval for the treatment of mantle cell lymphoma previously treated with a covalent BTK inhibitor may be subject to verification and description of clinical benefit in the confirmatory phase 3 trial, which is currently enrolling patients.

Jaypirca is anticipated to be available in the US in the coming weeks.

Jacob Van Naarden — Loxo@Lilly CEO, commenting on Jaypirca FDA approval, said: “We are pleased to bring a meaningful new therapeutic option to patients with MCL that can reestablish the benefit of targeting the BTK pathway after receiving multiple prior therapies, including a covalent BTK inhibitor.

“We are grateful to the patients, investigators, and other members of the clinical care teams for their contributions. Our team has been committed to rapidly advancing the development of Jaypirca for patients with MCL, and we look forward to building on this milestone by continuing to bring forward important new treatments for people with hematologic malignancies.”

Recently, Lilly announced an additional investment of $450 million to increase its production capacity at its Research Triangle Park facility in North Carolina.