FDA grants accelerated approval to mosunetuzumab|axgb

FDA accepts BLA for mosunetuzumab in relapsed or refractory ...

Scemblix (asciminib) was granted accelerated approval by FDA for adult patients with newly diagnosed Philadelphia chromosome-positive chronic ...

Cost-effectiveness analysis of mosunetuzumab for treatment of ...

Mosunetuzumab has received accelerated approval by the US Food and Drug Administration for adult patients with relapsed or refractory (R/R) follicular ...

New Approval Adds to Growing List of Therapies for B-cell Lymphoma

The US Food and Drug Administration (FDA) has granted accelerated approval to glofitamab-gxbm (Columvi) for select patients with B-cell lymphoma.

FDA Watch - Clinical Oncology News

The FDA approved mosunetuzumab-axgb (Lunsumio, Genentech) for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more ...

FDA Approvals of Biologics in 2022 - PMC - PubMed Central

LunsumioTM (mosunetuzumab), a humanized bispecific mAb, has received accelerated approval from the FDA this year. Indicated to treat a type of ...

Patient Guide to Lunsumio (Mosunetuzumab-axgb) for Follicular ...

The U.S. Food and Drug Administration (FDA) granted Lunsumio accelerated approval for follicular lymphoma, meaning that early clinical trial ...

FDA approval of LUNSUMIO™ (mosunetuzumab-axgb) the first-in ...

This indication is approved under accelerated approval based on response. Continued approval for this indication may be contingent upon ...

Bispecific Antibodies for Diffuse Large B-Cell Lymphoma and ...

Mosunetuzumab is a CD20xCD3 BsAb approved by the FDA for use in adults with R/R FL who have received 2 or more lines of systemic therapy.14 A phase 2, single- ...

FDA News: December 9, 2022, and February 3, 2023

On December 22, 2022, the FDA granted accelerated approval to mosunetuzumab-axgb (Lunsumio; Genentech), a bispecific CD20-directed CD3 T-cell engager, for ...

FDA Approvals of Biologics in 2022 - MDPI

FDA Grants Accelerated Approval to Mosunetuzumab-Axgb for Relapsed or Refractory Follicular Lymphoma. Available online: https://www.fda.gov ...

Upping the Ante with Bispecific and Trispecific Antibodies

S. Food & Drug Administration. FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma. December 23 ...

Matching-Adjusted Indirect Comparisons of Axicabtagene Ciloleucel ...

Food and Drug Administration. FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma. 2022; ...

Pharmacist's Application to Practice: Mosunetuzumab | HOPA

The efficacy and safety of mosunetuzumab was demonstrated in several phase I and II clinical trials in R/R non-hodgkin lymphoma (NHL), including FL. The FDA ...

MSK ASH 2023 Insights: Promising Results for Bispecific Antibodies ...

In December 2022, the FDA approved intravenous (IV) mosunetuzumab for treating patients with relapsed or refractory follicular lymphoma after ...

Matching-Adjusted Indirect Comparisons of Axicabtagene Ciloleucel ...

Mosunetuzumab is a CD20xCD3 bispecific antibody that was also the first of its class to be approved by the FDA for treatment of R/R 3L+ FL on ...

Lunsumio Gets FDA Accelerated Approval as Third Line Treatment ...

The US Food and Drug Administration (FDA) granted Roche's Lunsumio (mosunetuzumab) an accelerated approval near the end of 2022 for the ...

Mosunetuzumab, the First Bispecific Approved for Follicular ...

FDA.gov. FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma. https://www.fda.gov/drugs/resources-information- ...

FDA Grants Priority Review to Mosunetuzumab for Relapsed ...

The FDA has accepted a biologics license application and granted a priority review designation to mosunetuzumab, a potential first-in-class ...

FDA grants Breakthrough Therapy Designation for ... - Roche

“We are pleased that the FDA has granted Breakthrough Therapy Designation to mosunetuzumab, recognising the promising early efficacy data ...

LUNSUMIO™ (mosunetuzumab-axgb) for third-line or later follicular ...

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification ...