The FDA on July 30, 2018 approved AZEDRA® for adult and pediatric patients (12 years and older) with Iobenguane scan-positive, unresectable, locally advanced or metastatic Pheochromocytoma or Paraganglioma (PPGL) who require systemic anticancer therapy. AZEDRA® is a product of Progenics Pharmaceuticals, Inc.
Category: FDA Approvals
KISQALI® (Ribociclib)
The FDA on July 18, 2018 expanded the indication for KISQALI® in combination with an Aromatase Inhibitor for pre and perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. KISQALI® is a product of Novartis Pharmaceuticals Corporation.
TIBSOVO® (Ivosidenib)
The FDA on July 20, 2018 approved TIBSOVO® for adult patients with relapsed or refractory Acute Myeloid Leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test. TIBSOVO® is a product of Agios Pharmaceuticals, Inc.
XTANDI® (Enzalutamide)
The FDA on July 13, 2018 approved XTANDI® for patients with Castration-Resistant Prostate Cancer (CRPC). This approval broadens the indicated patient population to include patients with both non-metastatic CRPC (NM-CRPC) and metastatic CRPC. XTANDI® was previously approved for the treatment of patients with metastatic CRPC. XTANDI® is a product of Astellas Pharma US, Inc.
YERVOY® and OPDIVO®
The FDA on July 10, 2018 granted accelerated approval to YERVOY® (Ipilimumab), for use in combination with OPDIVO® (Nivolumab), for the treatment of patients 12 years of age and older with MicroSatellite Instability-High (MSI-H) or MisMatch Repair deficient (dMMR) metastatic Colorectal Cancer (mCRC), that has progressed following treatment with a Fluoropyrimidine, Oxaliplatin, and Irinotecan. YERVOY® and OPDIVO® are products of Bristol-Myers Squibb Company Inc.
BRAFTOVI® (Encorafenib) and MEKTOVI® (Binimetinib)
The FDA on June 27, 2018 approved BRAFTOVI® and MEKTOVI® in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. BRAFTOVI® and MEKTOVI® are products of Array BioPharma Inc.
KEYTRUDA® (Pembrolizumab)
The FDA on June 13, 2018 granted accelerated approval to KEYTRUDA® for the treatment of adult and pediatric patients with refractory Primary Mediastinal Large B-Cell Lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. KEYTRUDA® is a product of Merck and Co., Inc.
AVASTIN® (Bevacizumab)
The FDA on June 13, 2018 approved AVASTIN® for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with Carboplatin and Paclitaxel, followed by single-agent AVASTIN®, for stage III or IV disease, after initial surgical resection. AVASTIN® is a product of Genentech, Inc.
KEYTRUDA® (Pembrolizumab)
The FDA on June 12, 2018 approved KEYTRUDA® for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, whose tumors express PD-L1 (CPS 1 or more), as determined by an FDA-approved test. KEYTRUDA® is a product of Merck and Co., Inc.
VENCLEXTA® (Venetoclax)
The FDA on June 8, 2018 granted regular approval to VENCLEXTA® for patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. VENCLEXTA® is a product of AbbVie Inc. and Genentech Inc.