Regulatory status of midostaurin, enasidenib, CPX-351, gemtuzumab ozogamicin and venetoclax
| Drug and indication . | Regulatory status . |
|---|---|
| Midostaurin (Rydapt) | |
| Adult patients with newly diagnosed AML who are FLT3+, as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. | FDA approval 28 April 2017 |
| In combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single-agent maintenance therapy, for adult patients with newly diagnosed AML who are FLT3+. | European Medicines Agency approval 20 September 2017 |
| CPX-351 (Vyxeos) | |
| Treatment of adults with t-AML or AML with AML-MRC. | FDA approval 3 August 2017 |
| Enasidenib (Idhifa) | |
| Treatment of patients with relapsed or refractory AML with an IDH2 mutation detected with an FDA-approved assay. | FDA approval 1 August 2017 |
| Gemtuzumab ozogamicin (Mylotarg) | |
| Adults with newly diagnosed AML whose tumors express the CD33 antigen (CD33+ AML). Patients aged 2 y and older with CD33+ AML who have experienced a relapse or who have not responded to initial treatment (refractory). | FDA approval 1 September 2017 |
| Venetoclax (Venclexta) | |
| Venetoclax in combination with HMAs for the treatment of patients with untreated (treatment-naïve) AML who are ineligible to receive standard induction therapy (high-dose chemotherapy). | FDA breakthrough designation 28 January 2016 |
| Venetoclax in combination with LDAC for elderly patients with previously untreated AML who are ineligible for intensive chemotherapy. | FDA breakthrough designation 28 July 2017 |
| Drug and indication . | Regulatory status . |
|---|---|
| Midostaurin (Rydapt) | |
| Adult patients with newly diagnosed AML who are FLT3+, as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. | FDA approval 28 April 2017 |
| In combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single-agent maintenance therapy, for adult patients with newly diagnosed AML who are FLT3+. | European Medicines Agency approval 20 September 2017 |
| CPX-351 (Vyxeos) | |
| Treatment of adults with t-AML or AML with AML-MRC. | FDA approval 3 August 2017 |
| Enasidenib (Idhifa) | |
| Treatment of patients with relapsed or refractory AML with an IDH2 mutation detected with an FDA-approved assay. | FDA approval 1 August 2017 |
| Gemtuzumab ozogamicin (Mylotarg) | |
| Adults with newly diagnosed AML whose tumors express the CD33 antigen (CD33+ AML). Patients aged 2 y and older with CD33+ AML who have experienced a relapse or who have not responded to initial treatment (refractory). | FDA approval 1 September 2017 |
| Venetoclax (Venclexta) | |
| Venetoclax in combination with HMAs for the treatment of patients with untreated (treatment-naïve) AML who are ineligible to receive standard induction therapy (high-dose chemotherapy). | FDA breakthrough designation 28 January 2016 |
| Venetoclax in combination with LDAC for elderly patients with previously untreated AML who are ineligible for intensive chemotherapy. | FDA breakthrough designation 28 July 2017 |