Roche’s Lunsumio granted Priority Review by FDA for people with relapsed or refractory follicular lymphoma
Roche’s Lunsumio (mosunetuzumab) has been given a Priority Review by the US Food and Drug Administration (FDA) following its acceptance of the company’s Biologics License Application.
Lunsumio is a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody and it has been developed for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies.
Follicular lymphoma is the most common, slow-growth type of non-Hodgkin lymphoma (NHL) – a form of blood cancer – which often returns after a first therapy. Follicular lymphoma usually becomes more difficult to treat each time a patient relapses. In the US, estimates show around 13,000 new cases of FL will be diagnosed in 2022.
The FDA is expected to decide on the approval of the novel cancer immunotherapy by 29 December 2022.
If the treatment is approved, Lunsumio could be the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA for the treatment of any type of non-Hodgkin lymphoma.
Read more: https://www.pmlive.com/pharma_news/roches_lunsumio_granted_priority_review_by_fda_for_people_with_relapsed_or_refractory_follicular_lymphoma_1451616
Lunsumio is a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody and it has been developed for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies.
Follicular lymphoma is the most common, slow-growth type of non-Hodgkin lymphoma (NHL) – a form of blood cancer – which often returns after a first therapy. Follicular lymphoma usually becomes more difficult to treat each time a patient relapses. In the US, estimates show around 13,000 new cases of FL will be diagnosed in 2022.
The FDA is expected to decide on the approval of the novel cancer immunotherapy by 29 December 2022.
If the treatment is approved, Lunsumio could be the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA for the treatment of any type of non-Hodgkin lymphoma.
Read more: https://www.pmlive.com/pharma_news/roches_lunsumio_granted_priority_review_by_fda_for_people_with_relapsed_or_refractory_follicular_lymphoma_1451616
