^
    Back
    Association details:
    Biomarker:No biomarker
    Cancer:Diffuse Large B Cell Lymphoma
    Drug:Columvi (glofitamab-gxbm) (CD20 inhibitor, CD3 agonist)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Roche Press Release
    Title:

    European Commission approves Roche’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma

    Published date:
    07/11/2023
    Excerpt:
    Roche...announced today that the European Commission (EC) has granted conditional marketing authorisation for Columvi® (glofitamab) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy....The approval is based on positive results from a pivotal cohort in the phase I/II NP30179 study, where Columvi given as a fixed course induced early and long-lasting responses in people with R/R DLBCL.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Roche Press Release
    Title:

    FDA approves Roche’s Columvi, the first and only bispecific antibody with a fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma

    Published date:
    06/16/2023
    Excerpt:
    Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Columvi® (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    COLUMVI is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy....This indication is approved under accelerated approval based on response rate and durability of response.
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    NCCN
    Published date:
    07/07/2023
    Excerpt:
    Diffuse Large B-Cell Lymphoma….Bispecific T-cell engager therapy (only after at least two lines of systemic therapy; including patients with disease progression after transplant or CAR T-cell therapy) - Glofitamab-gxbm
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Roche Press Release
    Title:

    FDA grants priority review to Roche’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma

    Published date:
    01/06/2023
    Excerpt:
    Roche...today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted priority review for glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.