The FDA on April 20, 2020, granted accelerated approval to PEMAZYRE® for the treatment of adults with previously treated, unresectable locally advanced or metastatic Cholangiocarcinoma with a Fibroblast Growth Factor Receptor 2 (FGFR2) fusion or other rearrangement, as detected by an FDA-approved test. PEMAZYRE® is a product of Incyte Corporation.
Category: FDA Approvals
JELMYTO® (Mitomycin)
The FDA on April 15, 2020 approved JELMYTO® for adult patients with low-grade upper tract urothelial cancer. JELMYTO® is a product of UroGen Pharma.
TUKYSA® (Tucatinib)
The FDA on April 17, 2020 approved TUKYSA® in combination with Trastuzumab and XELODA® (Capecitabine), for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. TUKYSA® is a product of Seattle Genetics, Inc.
BRAFTOVI® (Encorafenib) and ERBITUX® (Cetuximab)
The FDA on April 8, 2020 approved BRAFTOVI® (Encorafenib), in combination with ERBITUX® (Cetuximab) for the treatment of adult patients with metastatic ColoRectal Cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy. BRAFTOVI® is a product of Array BioPharma Inc.
REBLOZYL® (Luspatercept-aamt)
The FDA on April 3, 2020, approved REBLOZYL® (Luspatercept-aamt) for the treatment of anemia, failing an Erythropoiesis Stimulating Agent, and requiring 2 or more RBC units over 8 weeks, in adult patients with very low- to intermediate-risk MyeloDysplastic Syndromes with Ring Sideroblasts (MDS-RS), or with MyeloDysplastic/MyeloProliferative Neoplasm with Ring Sideroblasts and Thrombocytosis (MDS/MPN-RS-T). REBLOZYL® is a product of Celgene Corporation.
IMFINZI® (Durvalumab)
The FDA on March 30, 2020 approved IMFINZI® in combination with Etoposide and either Carboplatin or Cisplatin as first-line treatment of patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC). IMFINZI® is a product of AstraZeneca.
OPDIVO® and YERVOY®
The FDA on March 10, 2020 granted accelerated approval to the combination of OPDIVO® (Nivolumab) and YERVOY® (Ipilimumab) for patients with Hepatocellular Carcinoma (HCC), who have been previously treated with NEXAVAR® (Sorafenib). Both OPDIVO® and YERVOY® are products of Bristol-Myers Squibb Co.
NERLYNX® (Neratinib)
The FDA on February 25, 2020 approved NERLYNX® in combination with XELODA® (Capecitabine) for adult patients with advanced or metastatic HER2-positive Breast Cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting. NERLYNX® is a product of Puma Biotechnology, Inc.
SARCLISA® (Isatuximab-irfc)
The FDA on March 2, 2020 approved SARCLISA® in combination with POMALYST® (Pomalidomide) and Dexamethasone for adult patients with Multiple Myeloma, who have received at least two prior therapies including REVLIMID® (Lenalidomide) and a Proteasome Inhibitor. SARCLISA® is a product of Sanofi-Aventis U.S. LLC.
TAZVERIK® (Tazemetostat)
The FDA on January 23, 2020 granted accelerated approval to TAZVERIK® for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma, not eligible for complete resection. TAZVERIK® is a product of Epizyme, Inc.