Roche's Follicular Lymphoma Therapy Scores FDA Approval

The FDA approved Roche Holding AG RHHBY unit Genentech's Lunsumio (mosunetuzumab-axgb) for relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
This indication is approved under accelerated approval based on response rate, making Lunsumio the first CD20xCD3 bispecific to be authorized for this form of non-Hodgkin lymphoma (NHL).
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Roche is already working on a follow-up to Lunsumio with a subcutaneous formulation.
Biogen Inc BIIB exercised an option on the development of Lunsumio, paying Genentech a $30-million fee as part of a long-standing collaboration on antibodies targeting CD20.
Under the agreed terms, Biogen will share in the operating profits and losses of the drug in the U.S. in the low- to mid-30% range.
The FDA approval is based on positive results from the Phase II GO29781 study of Lunsumio in people with heavily pre-treated FL, including those at high risk of disease progression or whose disease was refractory to prior therapies.
Results from the study showed high and durable response rates. An objective response was seen in 80% (72/90) of patients treated with Lunsumio, with a majority maintaining responses for at least 18 months (57%).
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