The FDA on April 19, 2018 approved TAGRISSO® for the first-line treatment of patients with metastatic Non Small Cell Lung Cancer (NSCLC), whose tumors have Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. TAGRISSO® is a product of AstraZeneca Pharmaceuticals LP.
Category: FDA Approvals
TAVALISSE® (Fostamatinib disodium hexahydrate)
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.
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.