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.
Category: FDA Approvals
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.
ROZLYTREK® (Entrectinib)
The FDA on August 15, 2019 granted accelerated approval to ROZLYTREK® for adults and pediatric patients 12 years of age and older with solid tumors that have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. ROZLYTREK® is a product of Genentech Inc.
TURALIO® (Pexidartinib)
The FDA on August 2, 2019 approved TURALIO® capsules for adult patients with symptomatic Tenosynovial Giant Cell Tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. TURALIO® is the first systemic therapy approved for patients with TGCT. TURALIO® is a product of Daiichi Sankyo, Inc.
KEYTRUDA® (Pembrolizumab)
The FDA on July 30, 2019 approved KEYTRUDA® for patients with recurrent, locally advanced or metastatic Squamous Cell Carcinoma of the Esophagus (ESCC), whose tumors express PD-L1 (Combined Positive Score-CPS of 10 or more), as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy. FDA also approved a new use for the PD-L1 IHC 22C3 pharmDx kit as a companion diagnostic device for selecting patients for the above indication. KEYTRUDA® is a product of Merck & Co., Inc.