Gilteritinib Fumarate and Nerlynx

• Generic Name: gilteritinib
• Dosage Forms: n.a.
• Other Brand Names: Xospata

For the treatment of relapsed or refractory AML harboring Flt-3 mutation (designated an orphan drug by FDA for this use).

FDA-approved companion diagnostic test (e.g., LeukoStrat CDx Flt-3 mutation assay) required to confirm presence of Flt-3 mutation prior to initiation of therapy.

• Generic Name: neratinib
• Dosage Forms: tablet
• Other Brand Names: Nerlynx

Nerlynx (neratinib) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Nerlynx is used to treat a certain type of early-stage breast cancer. It is used for this condition only if your tumor tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 protein can speed the growth of cancer cells.

Nerlynx is usually given after you have been treated with another medicine called trastuzumab (Herceptin).