The FDA on September 22, 2017 granted accelerated approval to OPDIVO®, for the treatment of HepatoCellular Carcinoma (HCC), in patients who have been previously treated with Sorafenib. OPDIVO® is a product of Bristol-Myers Squibb Co.
Month: October 2017
KEYTRUDA® (Pembrolizumab)
The FDA on September 22, 2017 granted accelerated approval to KEYTRUDA® for patients with recurrent locally advanced or metastatic, Gastric or GastroEsophageal Junction adenocarcinoma, whose tumors express PD-L1, as determined by an FDA-approved test. KEYTRUDA® is a product of Merck & Co., Inc.
ALIQOPA® (Copanlisib)
The FDA on September 14, 2017 granted accelerated approval to ALIQOPA®, for the treatment of adult patients with relapsed Follicular Lymphoma, who have received at least two prior systemic therapies. ALIQOPA® is a product of Bayer HealthCare Pharmaceuticals Inc.
JEVTANA® (Cabazitaxel)
The FDA on September 14, 2017 approved a lower dose of JEVTANA® (20 mg/m2 every 3 weeks) in combination with Prednisone for the treatment of patients with metastatic Castration-Resistant Prostate Cancer, previously treated with a Docetaxel-containing treatment regimen. JEVTANA® (25 mg/m2 every 3 weeks) was approved for this indication in 2010. JEVTANA® is a product of Sanofi-Aventis.
BESPONSA® (Inotuzumab ozogamicin)
The FDA on August 17, 2017 approved BESPONSA® for the treatment of adults with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL). BESPONSA® is a product of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.
LYNPARZA® (Olaparib)
The FDA on August 17, 2017 granted regular approval to LYNPARZA® tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. LYNPARZA® is a product of AstraZeneca.
MYLOTARG® (Gemtuzumab ozogamicin)
The FDA on September 1, 2017 approved MYLOTARG® for the treatment of newly-diagnosed CD33-positive Acute Myeloid Leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older. MYLOTARG® may be used in combination with Daunorubicin and Cytarabine for adults with newly diagnosed AML, or as a stand-alone treatment for certain adult and pediatric patients. MYLOTARG® is a product of Pfizer Inc.