FDA Oncology Announcements

Bcr-Abl inhibitor × Clear all

18 Announcements

FDA grants accelerated approval to ponatinib with chemotherapy for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia

Drug: Iclusig (ponatinib) · Bcr-Abl inhibitor
Conditions: LymphoidOther hematologic neoplasm

FDA approves bosutinib for pediatric patients with chronic myelogenous leukemia

Drug: Bosulif (bosutinib) · Bcr-Abl inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves nilotinib for pediatric patients with newly diagnosed or resistant/intolerant Ph+ CML in chronic phase

Trial: DIALOG
Drug: TASIGNA (nilotinib) · Bcr-Abl inhibitor
Condition: Myeloid

Nilotinib label update to include treatment discontinuation recommendations for CML with sustained molecular responses

Trials: ENESTfreedom, ENESTop
Drug: Tasigna (nilotinib) · Bcr-Abl inhibitor
Condition: Myeloid

FDA grants accelerated approval to bosutinib for treatment of newly-diagnosed PH+ CML

Drug: BOSULIF (bosutinib) · Bcr-Abl inhibitor
Condition: Myeloid

FDA approves dasatinib for pediatric patients with CML

Drug: SPRYCEL (dasatinib) · Bcr-Abl inhibitor
Condition: Myeloid

FDA Approves Ponatinib

Drug: Iclusig tablets (ponatinib) · Bcr-Abl inhibitor
Conditions: LymphoidMyeloid

Omacetaxine Mepesuccinate

Drug: SYNRIBO (omacetaxine mepesuccinate) · Bcr-Abl inhibitor
Condition: Myeloid

Bosutinib tablets

Drug: Bosulif (bosutinib) · Bcr-Abl inhibitor
Condition: Myeloid

Imatinib Mesylate Tablets

Drug: Gleevec (imatinib mesylate) · Bcr-Abl inhibitor
Condition: Sarcoma

Dasatinib (Sprycel)

Drug: Sprycel (dasatinib) · Bcr-Abl inhibitor
Condition: Myeloid

Nilotinib (Tasigna)

Drug: Tasigna Capsules (nilotinib) · Bcr-Abl inhibitor
Condition: Myeloid

Imatinib Mesylate

Drugs: Gleevec (imatinib mesylate tablets for oral use) · Bcr-Abl inhibitor, Gleevec (oral use)
Condition: Sarcoma

FDA Approves Dasatinib

Drug: Sprycel (dasatinib) · Bcr-Abl inhibitor
Conditions: LymphoidMyeloid

FDA Approves Nilotinib

Drug: Tasigna Capsules (nilotinib) · Bcr-Abl inhibitor
Condition: Myeloid

FDA approves imatinib mesylate (Gleevec) as a single agent for the treatment of multiple indications

Drug: Gleevec (imatinib mesylate) · Bcr-Abl inhibitor
Conditions: MyeloidSarcoma

FDA approves imatinib mesylate (Gleevec) to treat pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia

Drug: Gleevec (imatinib mesylate) · Bcr-Abl inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves dasatinib (Sprycel) for use in the treatment of adults with chronic phase, accelerated phase, or myeloid or lymphoid blast phase chronic myeloid leukemia

Drug: Sprycel (dasatinib) · Bcr-Abl inhibitor
Conditions: MyeloidOther hematologic neoplasm