News from the FDA/CDC

2018 at a glance: Recently approved therapies in oncology


Gilteritinib (Xospata)

Class: Inhibits the FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain (TKD).

Disease: Relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation.

Dose: 120 mg orally daily.

ADMIRAL trial (NCT02421939): 21% of the patients who received gilteritinib exhibited complete remission or complete remission with partial hematologic recovery.

2018 biosimilars

Glasdegib (Daurismo)

Class: Hedgehog pathway inhibitor.

Disease: Adults over age 75 years with newly diagnosed AML and other medical comorbidities that preclude them from intensive chemotherapy.

Dose: The recommended dose is 100 mg orally continuously in 28-day cycles.

AE: QT prolongation and embryo-fetal toxicity

Phase 2 BRIGHT 1003 trial (NCT01546038): 3.9-month overall survival advantage for glasdegib plus cytarabine, compared with cytarabine alone. Overall, 15% of the glasdegib plus low dose cytarabine arm achieved complete remission, compared with the 1% complete remission rate in patients who received cytarabine alone.

Iobenguane I 131 (Azedra)

Class: Radiopharmaceutical agent; induces cell death within the noradrenaline transporter.

Disease: Iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma

Dose: Initial intravenous dosimetric dose, followed by two therapeutic doses.

AE: Pancytopenia and elevated international normalized ratio (INR).

IB12B trial (NCT00874614): One-quarter of patients receiving this therapy had at least a 50% reduction in the dose and number of antihypertensives for at least 6 months; almost all patients had a tumor response.

Ivosidenib (Tibsovo)

Class: Small-molecule inhibitor of mutant isocitrate dehydrogenase (IDH1).

Disease: Refractory AML and an IDH1 mutation

Dose: 500 mg orally daily.

AG120-C-001 trial (NCT02074839): Overall response rate of 41.6% in patients who received ivosidenib, with a 30.4% rate of complete remission or complete remission with partial hematologic recovery.

Larotrectinib (Vitrakvi)

Class: Oral tyrosine kinase inhibitor.

Disease: Advanced solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

Dose: 100 mg orally twice daily.

LOXO-TRK-14001, SCOUT, and NAVIGATE trials (NCT02122913, NCT02637687, and NCT02576431): Patients who received larotrectinib had durable responses regardless of patient age, tumor type, and fusion status.

Lutetium Lu 177 dotatate (Lutathera)

Class: Radiolabeled somatostatin analogue.

Disease: Somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Dose: Intravenous infusion 7.4 GBq (200 mCi) every 8 weeks for a total of four doses.

NETTER-1 trial (NCT01578239): 65% of adults who received lutetium Lu 177 showed improved progression-free survival at 20 months, compared with just 10.8% in the control group.

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