FDA Updates

Federal health officials this week allowed a genetic testing firm to sell kits to consumers to test whether they carry gene mutations that put them at higher risk for breast and ovarian cancer.

Daratumumab (Darzalex), in combination with pomalidomide (Pomalyst) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 2 previous therapies, including lenalidomide (Revlimid) and a proteasome inhibitor, was approved by the FDA on June 16, 2017.

On August 1, 2017, the FDA approved enasidenib (Idhifa), an isocitrate dehydrogenase-2 inhibitor, for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) who have the IDH2 genetic mutation.

The FDA, on August 3, 2017, approved a fixed combination daunorubicin plus cytarabine (Vyxeos) injection for the treatment of adults with 2 types of acute myeloid leukemia (AML)—newly diagnosed, therapy-related AML (t-AML) and AML with myelodysplasia-related changes (AML-MRC).

Tisagenlecleucel (Kymriah), a genetically modified chimeric antigen receptor (CAR) T-cell immunotherapy, was approved by the FDA on August 30, 2017, for the treatment of pediatric patients and young adults aged ≤25 years with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).

On September 1, 2017, the FDA approved gemtuzumab ozogamicin (Mylotarg) for the treatment of adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), as well as patients aged ≥2 years with relapsed or refractory CD33-positive AML.

The FDA has granted accelerated approval to pembrolizumab for the treatment of any solid tumor in the body with a specific genetic feature, or biomarker.