The FDA has also approved BeOne’s application to participate in Project Orbis, an initiative that offers a framework for concurrent submission and oncology products review among collaborating health authorities.
BeOne senior vice-president and chief regulatory affairs officer Julie Lepin said: “Breakthrough therapy designation is reserved for medicines with the potential to transform outcomes for patients with serious diseases.
“This recognition affirms the strength of the emerging data for sonrotoclax and its potential to become a new standard of care for people with relapsed or refractory mantle cell lymphoma. Additionally, by participating in Project Orbis, we may be able to accelerate access to sonrotoclax, potentially helping patients faster than previously imagined.”
The FDA’s decision to award sonrotoclax breakthrough therapy designation and allow its participation in Project Orbis was based on data obtained from the BGB-11417-201 Phase I/II trial.
This study assessed the efficacy of sonrotoclax in adult patients suffering from R/R MCL, following treatment with an anti-CD20 therapy and Bruton’s tyrosine kinase inhibitor.
The newly announced positive topline results for sonrotoclax highlight its potential to provide lasting and deep responses.
BeOne intends to present the complete data at an upcoming medical conference. Meanwhile, the Phase III confirmatory CELESTIAL-RRMCL study is currently in progress.
This marks the first BTD for sonrotoclax and the second for the company’s haematology programme.
The FDA has additionally granted sonrotoclax fast track designation for MCL and Waldenström macroglobulinaemia (WM).
Furthermore, it has received orphan drug designation to treat adult patients with WM, multiple myeloma, MCL and acute myeloid leukaemia.