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Association details:
Biomarker:No biomarker
Cancer:Follicular Lymphoma
Drug:Lunsumio (mosunetuzumab-axgb) (CD20 inhibitor, CD3 agonist)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Title:

FDA approves Roche’s Lunsumio, a first-in-class bispecific antibody, to treat people with relapsed or refractory follicular lymphoma

Published date:
12/22/2022
Excerpt:
Roche...today announced that the U.S. Food and Drug Administration (FDA) has approved Lunsumio® (mosunetuzumab-axgb) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
Trial ID:
Evidence Level:
Sensitive: A1 - Approval
Source:
Excerpt:
LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
01/25/2023
Excerpt:
Follicular Lymphoma….Bispecific T-cell engager therapy: Mosunetuzumab-axgb added as a category 2A recommendation.
Evidence Level:
Sensitive: B - Late Trials
Title:

FDA grants Priority Review to Roche’s Lunsumio for people with relapsed or refractory follicular lymphoma

Published date:
07/06/2022
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 Lunsumio® (mosunetuzumab), a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies.