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.
Category: FDA Approvals
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.
FRAGMIN® (Dalteparin sodium)
The FDA on May 16, 2019 approved FRAGMIN®, to reduce the recurrence of symptomatic Venous ThromboEmbolism (VTE) in pediatric patients 1 month of age and older. FRAGMIN® is a product of Pfizer, Inc.
VENCLEXTA® (Venetoclax)
The FDA on May 15, 2019 approved VENCLEXTA® for adult patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). VENCLEXTA® is a product of AbbVie Inc. and Genentech Inc.
BAVENCIO® and INLYTA®
The FDA on May 14, 2019 approved BAVENCIO® (Avelumab) in combination with INLYTA® (Axitinib) for first-line treatment of patients with advanced Renal Cell Carcinoma (RCC). BAVENCIO® is a product of EMD Serono, Inc. and INLYTA® is a product of Pfizer, Inc.
CYRAMZA® (Ramucirumab)
The FDA on May 10, 2019 approved CYRAMZA® as a single agent for HepatoCellular Carcinoma (HCC) in patients who have an Alpha FetoProtein (AFP) of 400 ng/mL or more, and have been previously treated with NEXAVAR® (Sorafenib). CYRAMZA® is a product of Eli Lilly and Company.
KADCYLA® (Ado-trastuzumab Emtansine)
The FDA on May 3, 2019, approved KADCYLA® for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC), who have residual invasive disease after neoadjuvant Taxane and HERCEPTIN® (trastuzumab)-based treatment.KADCYLA® is a product of Genentech, Inc.
Patients should be selected based on an FDA-approved companion diagnostic for KADCYLA®. FDA also approved both the Ventana Medical Systems, Inc. PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody assay and the INFORM HER2 Dual ISH DNA Probe Cocktail assay as companion diagnostic devices for selecting patients.
TIBSOVO® (Ivosidenib)
The FDA on May 2, 2019 approved TIBSOVO® for newly diagnosed Acute Myeloid Leukemia (AML), with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy. TIBSOVO® was approved in July 2018 for adult patients with relapsed or refractory AML with a susceptible IDH1 mutation. TIBSOVO® is a product of Agios Pharmaceuticals, Inc.
KEYTRUDA® and INLYTA®
The FDA on April 19, 2019, approved KEYTRUDA® (Pembrolizumab) plus INLYTA® (Axitinib) for the first-line treatment of patients with advanced Renal Cell Carcinoma (RCC). KEYTRUDA® is a product of Merck & Co. Inc. and INLYTA® is a product of Pfizer Inc.
BALVERSA® (Erdafitinib)
The FDA on April 12, 2019 granted accelerated approval to BALVERSA® (Erdafitinib) for patients with locally advanced or metastatic Urothelial Carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations,that has progressed during or following Platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant Platinum-containing chemotherapy. Patients should be selected for therapy based on an FDA-approved companion diagnostic for BALVERSA®. The FDA also simultaneously approved the THERASCREEN® FGFR RGQ RT-PCR Kit, developed by QIAGEN, for use as a companion diagnostic for this therapeutic indication. BALVERSA® is a product of Janssen Pharmaceutical Companies.