The FDA on November 15, 2019 approved ADAKVEO® to reduce the frequency of Vaso-Occlusive Crises (VOCs) in adults and pediatric patients aged 16 years and older with Sickle Cell disease. ADAKVEO® is a product of Novartis Pharmaceuticals Corporation.
Category: FDA Approvals
GIVLAARI® (Givosiran)
The FDA on November 20, 2019 approved GIVLAARI® for adults with Acute Hepatic Porphyria (AHP). GIVLAARI® is a product of Alnylam Pharmaceuticals, Inc.
CALQUENCE® (Acalabrutinib)
The FDA on November 21, 2019 approved CALQUENCE® for adults with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). CALQUENCE® is a product of AstraZeneca.
OXBRYTA® (Voxelotor)
The FDA on November 25, 2019 granted accelerated approval to OXBRYTA® for adults and pediatric patients 12 years of age and older with Sickle Cell disease. OXBRYTA® is a product of Global Blood Therapeutics.
ZEJULA® (Niraparib)
The FDA on October 23, 2019 approved ZEJULA® for patients with advanced Ovarian, Fallopian tube, or Primary Peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with Homologous Recombination Deficiency (HRD)-positive status. HDR is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression greater than six months after response to the last Platinum-based chemotherapy. ZEJULA® is a product of Tesaro, Inc.
DARZALEX® (Daratumumab)
The FDA on September 26, 2019 approved DARZALEX® for adult patients with Multiple Myeloma in combination with VELCADE® (Bortezomib), THALOMID® (Thalidomide), and Dexamethasone in newly diagnosed patients who are eligible for Autologous Stem Cell Transplant (ASCT). DARZALEX® is a product of Janssen Biotech, Inc.
ERLEADA® (Apalutamide)
The FDA on September 17, 2019 approved ERLEADA® for patients with metastatic Castration-Sensitive Prostate Cancer (CSPC). ERLEADA® was initially approved in 2018 for patients with non-metastatic Castration-Resistant Prostate Cancer (CRPC). ERLEADA® is a product of Janssen Biotech, Inc.
KEYTRUDA® (Pembrolizumab) and LENVIMA® (Lenvatinib)
The FDA on September 17, 2019 granted accelerated approval to the combination of KEYTRUDA® and LENVIMA® for the treatment of patients with advanced Endometrial carcinoma that is not MicroSatellite Instability High (MSI-H) or MisMatch Repair deficient (dMMR), and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. KEYTRUDA® is a product of Merck & Co and LENVIMA® is a product of Eisai Inc.
INREBIC® (Fedratinib)
The FDA on August 16, 2019 approved INREBIC® for adults with intermediate-2 or high-risk Primary or Secondary (post-Polycythemia Vera or post-Essential Thrombocythemia) Myelofibrosis (MF). INREBIC® is a product of Impact Biomedicines, Inc.
ROZLYTREK® (Entrectinib)
The FDA on August 15, 2019 approved ROZLYTREK® for adults with metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors are ROS1-positive. ROZLYTREK® is a product of Genentech Inc.