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.
Category: FDA Approvals
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.
KEYTRUDA® (Pembrolizumab)
The FDA on March 15, 2017 granted accelerated approval to KEYTRUDA® injection for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy. KEYTRUDA® is a product of Merck Sharp & Dohme Corp.