The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to sonrotoclax, a next-generation investigational BCL-2 inhibitor, in adult patients with relapsed or refractory mantle cell lymphoma (MCL). The therapy is manufactured by BeOne.
The FDA also accepted the company’s request to join Project Orbis, a program initiated by the FDA Oncology Center of Excellence for concurrent oncology reviews among global regulators.
The FDA designation was granted based on positive topline results in the phase 1/2 BGB-11417-201 study (NCT05471843), which evaluated sonrotoclax in patients with relapsed or refractory MCL after Bruton’s tyrosine kinase inhibitor and anti-CD20 therapy.
BeOne plans to present full data at an upcoming medical meeting; the company also announced that the phase 3 confirmatory CELESTIAL-RRMCL study (BGB-11417-302; NCT06742996) is underway.
“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,” said Julie Lepin, senior vice president and chief regulatory affairs officer at BeOne, in the company press release announcing the designation.
