Roche (SIX:RO, ROG; OTCQX:RHHBY) has announced that it has accepted the company’s Biologics License Application (BLA) and granted priority review for Lunsumio (mosunetuzumab), a CD20xCD3 T-cell engaging bispecific antibody developed by the company’s Genentech subsidiary.
In February, Biogen (Nasdaq:BIIB) said it would pay $30 million to exercise an option to participate in the development and commercialization of the drug candidate.
Basel, Switzerland-based Roche believes mosunetuzumab holds potential for adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two other systemic therapies.
Follicular lymphoma arises from B-lymphocytes and is a common slow-growing form of non-Hodgkin lymphoma (NHL).
Approximately one in five patients with follicular lymphoma relapse within two years of diagnosis, according to an article in the ASCO Post.
Lunsumio would be a fixed-duration treatment that could potentially be administered in an outpatient setting.
FDA anticipates making a decision on mosunetuzumab by 29 December 2022
“New therapeutic options are needed for follicular lymphoma, which often relapses after initial therapy and becomes increasingly difficult to treat each time it returns. Clinical trial results have demonstrated durable responses with Lunsumio in advanced follicular lymphoma, representing a step toward shifting the treatment paradigm,” said Dr. Levi Garraway, Roche’s chief medical officer and head of global product development. “Since Lunsumio does not require the collection or genetic modification of patient cells, it could become an effective, fixed-duration outpatient option without the barriers of traveling to a major academic center,” Garray added in a news release.
The priority review was based on data from a pivotal Phase 1/2 trial that associated Lunsumio with high and durable complete response rates in previously treated follicular lymphoma.