Genentech Provides Update on FDA Advisory Committee Meeting on Columvi Combination for People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Genentech has announced updates following the FDA’s Oncologic Drugs Advisory Committee (ODAC) meeting regarding Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for treating relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). This combination could offer a significant survival benefit for patients who are not candidates for autologous stem cell transplant (ASCT).

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Key Points

  • Columvi is the first bispecific antibody to demonstrate a significant survival benefit of 41% in R/R DLBCL.
  • There is an urgent need for accessible therapies for patients with transplant-ineligible R/R DLBCL.
  • The Columvi combination offers an off-the-shelf, fixed-duration treatment option for patients with poor prognosis.
  • The STARGLO study’s results are representative of U.S. patient demographics.
  • The FDA is reviewing the sBLA, with a decision on approval expected by July 20, 2025.

Why should I read this?

If you’re following cancer treatment advancements, this article is essential! Genentech’s Columvi is poised to change the game for people with R/R DLBCL, offering hope where few options exist. Catch the details on how this could reshape treatment opportunities and keep an eye on the FDA’s upcoming decisions!