Ono moves towards new BTK inhibitor launch

A second-generation BTK inhibitor from Ono Pharmaceuticals could be heading for the US market by year-end, after the FDA accepted a filing seeking accelerated approval in primary central nervous system lymphoma (PCNSL). The agency has set a 18 December action date for tirabrutinib, an irreversible BTK inhibitor that has already been approved in Japan, as Velexbru, and once sat in the oncology pipeline of Gilead. The company held global rights outside parts of Asia, including Japan, South Korea and China, before handing these back to Ono in 2021. The application rests on data from the phase 2 Prospect trial, presented at ASCO. In 48 patients with relapsed or refractory PCNSL treated with tirabrutinib monotherapy, the drug delivered a 67% response rate and a median progression-free survival of 6 months. A confirmatory head-to-head study is ongoing, pitting tirabrutinib against Rituxan and Temodar in PCNSL patients. This regulatory milestone comes a couple of weeks after Gilead scored a separate win in this indication. The company said that relapsed/refractory PCNSL was removed from the FDA’s limitations of use for its Car-T therapy Yescarta, following results from a Phase 1 investigator-sponsored study.

Selected trials of Velexbru in PCNSL

Source: OncologyPipeline.