The FDA on January 26, 2018 approved LUTATHERA®, a radiolabeled Somatostatin analog, for the treatment of Somatostatin receptor-positive GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors, in adults. LUTATHERA® is a product of Advanced Accelerator Applications USA, Inc.
Category: FDA Approvals
GILOTRIF® (Afatinib)
The FDA on January 12, 2018 granted approval to GILOTRIF® for a broadened indication in first-line treatment of patients with metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors have non-resistant Epidermal Growth Factor Receptor (EGFR) mutations, as detected by an FDA-approved test. GILOTRIF® is a product of Boehringer Ingelheim Pharmaceutical, Inc.
LYNPARZA® (Olaparib)
The FDA on January 12, 2018, granted regular approval to LYNPARZA® tablets, a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer, who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting. LYNPARZA® is a product of AstraZeneca Pharmaceuticals LP.
FDA Approves OPDIVO® for Adjuvant Treatment of Malignant Melanoma
The FDA on December 20, 2017, granted regular approval to the anti-PD1 monoclonal antibody, OPDIVO® (Nivolumab) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. The approved adjuvant therapies over the past two decades, for patients with high-risk melanoma have included high-dose INTRON® A (Interferon alfa-2b), SYLATRON® (peginterferon alfa-2b), and high-dose YERVOY® (Ipilimumab). The significant toxicities associated with these adjuvant interventions, precluded the wide spread use of adjuvant therapy in high risk melanoma.
OPDIVO® is a less toxic, better tolerated, adjuvant treatment option than YERVOY®, for patients with resected stage IIIB/C and IV melanoma, regardless of BRAF mutation. The Recurrence Free Survival rate at 18 months with OPDIVO® was 66.4% compared with 52.7% for YERVOY® and this meant a 35% reduction in the risk of recurrence or death with the OPDIVO® versus YERVOY®. This will fulfill the unmet need for adjuvant therapies, with improved benefit-risk ratio, for this patient group.
TASIGNA® (Nilotinib)
The FDA on December 22, 2017 updated the product label for TASIGNA® to include information on TASIGNA® discontinuation, post-discontinuation monitoring criteria, and guidance for treatment re-initiation in patients taking TASIGNA® for Philadelphia chromosome positive (Ph+) Chronic Myeloid Leukemia (CML) who have achieved a sustained Molecular Response (MR 4.5). TASIGNA® is a product of Novartis Pharmaceuticals Corp.
SIKLOS® (Hydroxyurea)
The FDA on December 21, 2017 granted regular approval to SIKLOS® to reduce the frequency of painful crises and the need for blood transfusions in pediatric patients from 2 years of age and older with sickle cell anemia with recurrent moderate to severe painful crises. SIKLOS® is a product of Addmedica.
PERJETA® (Pertuzumab)
The FDA on December 20, 2017 granted regular approval to PERJETA® for use in combination with Trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. PERJETA® is a product of Genentech, Inc.
OPDIVO® (Nivolumab)
The FDA on December 20, 2017 granted regular approval to the anti-PD1 monoclonal antibody OPDIVO® for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. OPDIVO® was previously approved for the treatment of patients with unresectable or metastatic melanoma. OPDIVO® is a product of Bristol-Myers Squibb Company.
OGIVRI® (Trastuzumab-dkst)
The FDA on December 1, 2017 approved OGIVRI® as a Biosimilar to HERCEPTIN® (Trastuzumab, Genentech, Inc.) for the treatment of patients with HER2-overexpressing breast or metastatic stomach cancer (Gastric or GastroEsophageal junction adenocarcinoma). OGIVRI® is a product of Mylan N.V.
CABOMETYX® (Cabozantinib)
The FDA on December 19, 2017 granted regular approval to CABOMETYX® for treatment of patients with advanced Renal Cell Carcinoma (RCC). CABOMETYX® is a product of Exelixis, Inc.