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%). 
  • Price Action: RHHBY shares are up 0.06% at $39.54 on the last check Friday.
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