The FDA on April 17, 2018 approved TAVALISSE® for the treatment of thrombocytopenia in adult patients with chronic Immune Thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. TAVALISSE® is a product of Rigel Pharmaceuticals, Inc.
Category: FDA Approvals
OPDIVO® (Nivolumab) and YERVOY® (Ipilimumab)
The FDA on April 16, 2018 granted approvals to OPDIVO® and YERVOY® in combination, for the treatment of intermediate or poor risk, previously untreated advanced Renal Cell Carcinoma. OPDIVO® and YERVOY® are products of Bristol-Myers Squibb Co.
AFINITOR® (Everolimus)
The FDA on April 10, 2018 approved AFINITOR® for the adjunctive treatment of adult and pediatric patients aged 2 years and older with Tuberous Sclerosis Complex (TSC)-associated partial-onset seizures. AFINITOR® is also approved for two other manifestations of TSC: TSC-associated SubEpendymal Giant cell Astrocytoma (SEGA) and TSC-associated renal angiomyolipoma. AFINITOR® is a product of Novartis Pharmaceuticals Corp.
RUBRACA® (Rucaparib)
The FDA on April 6, 2018 approved RUBRACA®, a Poly ADP-Ribose Polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a Complete or Partial Response to platinum-based chemotherapy. RUBRACA® is a product of Clovis Oncology Inc.
BLINCYTO® (Blinatumomab)
The FDA on March 29, 2018 granted accelerated approval to BLINCYTO® for the treatment of adult and pediatric patients with B-cell precursor Acute Lymphoblastic Leukemia (ALL) in first or second complete remission with Minimal Residual Disease (MRD) greater than or equal to 0.1%. BLINCYTO® is a product of Amgen Inc.
TASIGNA® (Nilotinib)
The FDA on March 22, 2018 approved TASIGNA® for pediatric patients 1 year of age or older with newly diagnosed Philadelphia chromosome positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior Tyrosine Kinase Inhibitor (TKI) therapy. TASIGNA® is a product of Novartis Pharmaceuticals Corporation.
ADCETRIS® (Brentuximab vedotin)
The FDA on March 20, 2018 approved ADCETRIS® to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy. ADCETRIS® is a product of Seattle Genetics, Inc.
VERZENIO® (Abemaciclib)
The FDA on February 26, 2018 approved VERZENIO® in combination with an Aromatase Inhibitor, as initial endocrine-based therapy for postmenopausal women with Hormone Receptor (HR)-positive, Human Epidermal growth factor Receptor 2 (HER2)-negative advanced or metastatic breast cancer. VERZENIO® is a product of Eli Lilly and Company.
IMFINZI® (Durvalumab)
The FDA on February 16, 2018 approved IMFINZI® for patients with unresectable stage III Non-Small Cell Lung Cancer (NSCLC,) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. IMFINZI® is a product of AstraZeneca Inc.
FDA Approves ZYTIGA® for High-Risk Metastatic Castration-Sensitive Prostate Cancer
The FDA on February 7, 2018, approved ZYTIGA® (Abiraterone acetate) in combination with Prednisone for metastatic high-risk Castration Sensitive Prostate Cancer (CSPC). The FDA initially approved ZYTIGA® with prednisone in 2011 for patients with metastatic Castration Resistant Prostate Cancer (CRPC), who had received prior chemotherapy, and the FDA expanded the indication in 2012, for patients with chemo naïve metastatic CRPC. The addition of ZYTIGA® along with Prednisone, to Androgen Deprivation Therapy, significantly increased Overall Survival and radiographic Progression Free Survival, in men with newly diagnosed, metastatic, Castration Sensitive Prostate Cancer. The new approval will change the treatment landscape for patients with metastatic CSPC.