The US FDA on June 22, 2017, granted regular approval to the combination of RITUXAN® (Rituximab) and Hyaluronidase human (RITUXAN HYCELA®) for adult patients with Follicular Lymphoma, Diffuse Large B-Cell Lymphoma, and Chronic Lymphocytic Leukemia. This Subcutaneous formulation of RITUXAN® utilizes ENHANZE®, a drug delivery technology platform, which removes limitations on the volume of biologics and drugs that can be delivered Subcutaneously, thereby significantly reducing the time required for drug administration. The approval of RITUXAN HYCELA® was based on several randomized clinical trials that demonstrated Non-inferior pharmacokinetics of Subcutaneous RITUXAN HYCELA® compared with IV RITUXAN®, as well as comparable efficacy and safety results.
Category: FDA Approvals
ALUNBRIG® (Brigatinib)
The FDA on April 28, 2017 granted accelerated approval to ALUNBRIG ® tablets for the treatment of patients with metastatic Anaplastic Lymphoma Kinase (ALK)-positive Non-Small Cell Lung Cancer (NSCLC), who have progressed on or are intolerant to XALKORI® (Crizotinib). ALUNBRIG® is a product of Takeda Pharmaceutical Company Limited, through its wholly owned subsidiary ARIAD Pharmaceuticals, Inc.
RYDAPT® (Midostaurin)
The FDA on April 28, 2017 approved RYDAPT® for the treatment of adult patients with newly diagnosed Acute Myeloid Leukemia (AML) who are FLT3 mutation-positive (FLT3+), as detected by an FDA-approved test, in combination with standard Cytarabine and Daunorubicin induction and Cytarabine consolidation. RYDAPT® is a product of Novartis Pharmaceuticals Corp.
STIVARGA® (Regorafenib)
The FDA on April 27, 2017 expanded the indications of STIVARGA® to include the treatment of patients with HepatoCellular Carcinoma (HCC) who have been previously treated with NEXAVAR® (Sorafenib). STIVARGA® is a product of Bayer HealthCare Pharmaceuticals Inc.
IBRANCE® (Palbociclib)
The FDA on March 31, 2017 granted regular approval to IBRANCE® for the treatment of Hormone Receptor (HR) positive, Human Epidermal growth factor Receptor 2 (HER2) negative advanced or metastatic breast cancer, in combination with an Aromatase Inhibitor, as initial endocrine based therapy in postmenopausal women. IBRANCE® is marketed by Pfizer Inc.
TAGRISSO® (Osimertinib)
The FDA on March 30, 2017 granted regular approval to TAGRISSO®, for the treatment of patients with metastatic Epidermal Growth Factor Receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR Tyrosine Kinase Inhibitor (TKI) therapy. TAGRISSO® is marketed by AstraZeneca Pharmaceuticals, LP.
BAVENCIO® (Avelumab)
The FDA on May 9, 2017 granted accelerated approval to BAVENCIO® for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. BAVENCIO® is a product of EMD Serono, Inc.
IMFINZI® (Durvalumab)
The FDA on May 1, 2017 granted accelerated approval to IMFINZI®, for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. IMFINZI® is marketed by AstraZeneca UK Limited.
ZEJULA® (Niraparib)
The FDA on March 27, 2017 approved ZEJULA®, a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. ZEJULA® is marketed by Tesaro, Inc.
BAVENCIO® (Avelumab)
The FDA on March 23, 2017 granted accelerated approval to BAVENCIO® for the treatment of patients 12 years and older with metastatic Merkel Cell Carcinoma (MCC). BAVENCIO® is a programmed death-ligand 1 (PD-L1) blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type of cancer. BAVENCIO® is a marketed by EMD Serono, Inc.