FDA Oncology Announcements

PI3K delta inhibitor × Clear all

4 Announcements

FDA grants accelerated approval to umbralisib for marginal zone lymphoma and follicular lymphoma

Trial: UNITY-NHL
Drug: Ukoniq (umbralisib) · PI3K delta inhibitor
Condition: Lymphoid

duvelisib (COPIKTRA, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Trial: DYNAMO + R
Drug: COPIKTRA (duvelisib) · PI3K delta inhibitor
Conditions: LymphoidOther hematologic neoplasm

FDA grants accelerated approval to copanlisib for relapsed follicular lymphoma

Drug: ALIQOPA (copanlisib) · PI3K delta inhibitor
Condition: Lymphoid

Idelalisib

Drugs: Zydelig tablets (idelalisib) · PI3K delta inhibitor, rituximab · Anti-CD20 antibody
Condition: Lymphoid