FDA grants Jaypirca accelerated approval for rare blood disorder

The US Food and Drug Administration (FDA) has granted accelerated approval to Jaypirca (pirtobrutinib) for relapsed or refractory mantle cell lymphoma (MCL) - a rare blood disorder - after at least two lines of systemic therapy, including a BTK inhibitor.

The approval was granted to Loxo@Lilly, the oncology unit of US pharma major Eli Lilly (NYSE: LLY), which noted that continued approval under the Accelerated Approval pathway for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial, and said that Jaypirca is expected to be available in the USA in the coming weeks. The company has indicated a list price of $21,00 for a 30-day supply of the treatment in the USA.

"We are pleased to bring a meaningful new therapeutic option to patients with MCL that can re-establish the benefit of targeting the BTK pathway after receiving multiple prior therapies, including a covalent BTK inhibitor," said Jacob Van Naarden, chief executive of Loxo@Lilly. "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," he added.