The FDA on July 30, 2019 approved NUBEQA® for non-metastatic Castration-Resistant Prostate Cancer (CRPC). NUBEQA® is a product of Bayer HealthCare Pharmaceuticals Inc.
Category: FDA Approvals
XPOVIO® (Selinexor)
The FDA on July 3, 2019 granted accelerated approval to XPOVIO® in combination with Dexamethasone for adult patients with Relapsed or Refractory Multiple Myeloma (RRMM) who have received at least four prior therapies, and whose disease is refractory to at least two Proteasome Inhibitors, at least two Immunomodulatory agents, and an anti-CD38 monoclonal antibody. XPOVIO® is a product of Karyopharm Therapeutics.
DARZALEX® (Daratumumab)
The FDA on June 27, 2019 approved DARZALEX® in combination with REVLIMID® (Lenalidomide) and Dexamethasone for patients with newly diagnosed Multiple Myeloma who are ineligible for Autologous Stem Cell Transplant. DARZALEX® is a product of Janssen Biotech, Inc.
KEYTRUDA® (Pembrolizumab)
The FDA on June 17, 2019 granted accelerated approval to KEYTRUDA® for patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. KEYTRUDA® is a product of Merck.
KEYTRUDA® (Pembrolizumab)
The FDA on June 10, 2019 approved KEYTRUDA® for the first-line treatment of patients with metastatic or unresectable recurrent Head and Neck Squamous Cell Carcinoma (HNSCC). KEYTRUDA® is a product of Merck.
POLIVY® (Polatuzumab vedotin-piiq)
The FDA on June 10, 2019 granted accelerated approval to POLIVY®, a CD79b-directed Antibody-Drug Conjugate indicated in combination with Bendamustine and a Rituximab product for adult patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL), Not Otherwise Specified, after at least two prior therapies. POLIVY® is a product of Genentech, Inc.
XOSPATA® (Gilteritinib)
The FDA on May 29, 2019 approved the addition of overall survival data in labeling for XOSPATA®, indicated for adult patients who have relapsed or refractory Acute Myeloid Leukemia (AML) with a FLT3 mutation, as detected by an FDA-approved test. XOSPATA® is a product of Astellas Pharma US, Inc.
REVLIMID® (Lenalidomide)
The FDA on May 28, 2019 approved REVLIMID® in combination with a RITUXAN® (Rituximab) for previously treated Follicular Lymphoma (FL) and previously treated Marginal Zone Lymphoma (MZL). REVLIMID® is a product of Celgene Corp.
PIQRAY® (Alpelisib)
The FDA on May 24, 2019 approved PIQRAY® in combination with FASLODEX® (Fulvestrant) for postmenopausal women, and men, with Hormone Receptor (HR)-positive, Human Epidermal growth factor Receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen. PIQRAY® is a product of Novartis Pharmaceuticals Corporation.
JAKAFI® (Ruxolitinib)
The FDA on May 24, 2019 approved JAKAFI® for steroid-refractory acute Graft-Versus-Host Disease (GVHD) in adult and pediatric patients 12 years and older. JAKAFI® is a product of Incyte Corporation.