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Roche's Investigational Lymphoma Candidate Goes Under FDA Priority Review

Benzinga · 01/06/2023 08:04
  • The FDA has accepted Roche Holdings AG's (OTC: RHHBY) Biologics License Application (BLA) and granted priority review for glofitamab for relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. 
  • LBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and is one of the most prevalent types of blood cancer among adults in the U.S.
  • The FDA is expected to decide on the approval of this novel cancer immunotherapy by 1 July 2023. 
  • Related: Roche Presents New Data Demonstrating Potential Benefit Of Two Lymphoma Candidates.
  • If approved, glofitamab would be the first fixed-duration, off-the-shelf CD20xCD3 T-cell engaging bispecific antibody available to treat people with aggressive lymphoma who have previously received multiple courses of treatment.
  • The application is based on data from the pivotal Phase 1/2 NP30179 study. Results showed that 40.0% of patients (n=62/155) achieved a complete response (CR; a disappearance of all signs of cancer), and 51.6% (n=80/155) achieved an objective response (OR; the combination of CR and partial response, a decrease in the amount of cancer in their body). 
  • The median follow-up time was 13.4 months. Among those who achieved a CR, 73.1% continued to experience a response at 12 months, while the median duration of CR was not reached. The median duration of response was 18.4 months.