FDA Approvals, News & Updates
Best Practices in Hematologic Malignancies – December 2017 Vol 8 | December 15, 2017
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).
Best Practices in Hematologic Malignancies – December 2017 Vol 8 | December 15, 2017
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).
Best Practices in Hematologic Malignancies – December 2017 Vol 8 | December 15, 2017
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.
Best Practices in Immunotherapy – June/July 2017 Vol 8 | July 19, 2017
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.
