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FDA approves Roche's Lunsumio


FDA approves Roche's Lunsumio, a first-in-class bispecific antibody ...

FDA approves Roche's Lunsumio, a first-in-class bispecific antibody, to treat people with relapsed or refractory follicular lymphoma · About the ...

FDA approval of Lunsumio (mosunetuzumab-axgb) for adult patients ...

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

FDA grants accelerated approval to mosunetuzumab-axgb

On December 22, 2022, the Food and Drug Administration (FDA) granted accelerated approval to mosunetuzumab-axgb (Lunsumio, Genentech, Inc.), ...

Press Releases | Thursday, Dec 22, 2022 - Genentech

The FDA approval is based on positive results from the Phase II GO29781 study of Lunsumio in people with heavily pretreated FL, including those ...

Lunsumio gets FDA sign off to treat follicular lymphoma

Upon the FDA approval for its bispecific antibody Lunsumio (mosunetuzumab) as a third-line therapy for follicular lymphoma, Roche was quick ...

FDA grants Priority Review to Roche's Lunsumio for people with ...

Lunsumio® (mosunetuzumab) could be the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA for the treatment of any type ...

Roche's Lunsumio Lands FDA Approval for Pretreated Follicular ...

Roche's Lunsumio Lands FDA Approval for Pretreated Follicular Lymphoma ... After gaining European approval in June, Roche's bispecific antibody, ...

FDA approves drugs from Gilead, Roche, TG Therapeutics to close ...

Approval of Roche's Lunsumio, meanwhile, marks another milestone, as it's the first bispecific antibody approved by the FDA that targets ...

Roche Bi-Specific Antibody Approved by FDA for a Relapsed or ...

Late last week, big pharma company Roche announced FDA approval of its bi-specific antibody Lunsumio for the treatment of people with a ...

FDA Approves Roche Lymphoma Drug, Bringing Competition to ...

The FDA approved Roche's Columvi as a third-line treatment for a type of blood cancer called diffuse large B-cell lymphoma. This new Roche drug ...

FDA approves Roche's Columvi, the first and only bispecific

Roche's haematology bispecific antibody portfolio also includes Lunsumio® (mosunetuzumab), which was granted accelerated approval by the FDA ...

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

Roche's Lunsumio has received FDA approval as the first-in-class bispecific antibody for the treatment of follicular lymphoma.

FDA approves Roche's Lunsumio, a first-in-class bispecific antibody ...

Roche announced that the U.S. Food and Drug Administration (FDA) has approved Lunsumio® (mosunetuzumab-axgb) for the treatment of adult patients with ...

Lunsumio - accessdata.fda.gov

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 2 DOSAGE AND ...

Switzerland : FDA approves Roches Lunsumio, a - ProQuest

Switzerland : FDA approves Roches Lunsumio, a first-in-class bispecific antibody, to treat people with relapsed or refractory follicular lymphoma. MENA ...

Press Releases | Thursday, Jun 15, 2023 - Genentech

The FDA accelerated approval is based on positive results from the Phase I/II NP30179 study of Columvi given as a fixed course for 8.5 months in ...

U.S. FDA approves Roche's lymphoma therapy | Reuters

The U.S. health regulator has approved Roche Holding AG's therapy for treating a type of rare cancer called follicular lymphoma.

AbbVie's Epkinly follows Roche's Lunsumio into FL - Fierce Pharma

With Regeneron's treatment delayed, AbbVie is expanding its T-cell engager competition against Roche in blood cancer with a new FDA approval ...

FDA Approves Mosunetuzumab for Relapsed/Refractory Follicular ...

The FDA has approved mosunetuzumab-axgb (Lunsumio) for patients with relapsed/refractory follicular lymphoma after 2 prior lines of therapy, ...

FDA grants priority review to Roche's Lunsumio for follicular lymphoma

The US FDA has granted priority review to Roche's BLA of Lunsumio (mosunetuzumab) to treat adults with R/R follicular lymphoma (FL).