FDA Oncology Announcements

Anti-CD20-CD3 bispecific × Clear all

5 Announcements

FDA approves epcoritamab-bysp for follicular lymphoma indications

Trial: EPCORE FL-1
Drugs: Epkinly (epcoritamab-bysp) · Anti-CD20-CD3 bispecific antibody, lenalidomide · Immunomodulatory drugs (IMiDs), rituximab · Anti-CD20 antibody
Condition: Lymphoid

FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma

Trial: EPCORE™ NHL-1
Drug: Epkinly (epcoritamab-bysp) · Anti-CD20-CD3 bispecific antibody
Condition: Lymphoid

FDA grants accelerated approval to glofitamab-gxbm for selected relapsed or refractory large B-cell lymphomas

Drug: Columvi (glofitamab-gxbm) · Anti-CD20-CD3 bispecific antibody
Condition: Lymphoid

FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma

Drug: Epkinly (epcoritamab-bysp) · Anti-CD20-CD3 bispecific antibody
Condition: Lymphoid

FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma

Drug: Lunsumio (mosunetuzumab-axgb) · Anti-CD20-CD3 bispecific antibody
Condition: Lymphoid