The FDA on July 20, 2023, approved VANFLYTA® (Quizartinib) with standard Cytarabine and Anthracycline induction and Cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed Acute Myeloid Leukemia (AML) that is FLT3 Internal Tandem Duplication (ITD)-positive, as detected by an FDA-approved test. VANFLYTA® is a product of Daiichi Sankyo, Inc.
Category: FDA Approvals
TALZENNA® (Talazoparib) with Enzalutamide
The FDA on June 20, 2023, approved TALZENNA® with Enzalutamide for Homologous Recombination Repair (HRR) gene-mutated metastatic Castration-Resistant Prostate Cancer (mCRPC). TALZENNA® is a product of Pfizer, Inc.
COLUMVI® (Glofitamab-gxbm)
The FDA on June 15, 2023, granted accelerated approval to COLUMVI® for Relapsed or Refractory Diffuse Large B-Cell Lymphoma, not otherwise specified (DLBCL, NOS) or Large B-Cell Lymphoma (LBCL) arising from Follicular Lymphoma, after two or more lines of systemic therapy. COLUMVI® is a product of Genentech, Inc.
LYNPARZA® (Olaparib)
The FDA on May 31, 2023, approved LYNPARZA® (Olaparib) along with Abiraterone and Prednisone (or Prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic Castration-Resistant Prostate Cancer (mCRPC), as determined by an FDA-approved companion diagnostic test. LYNPARZA® is a product of AstraZeneca Pharmaceuticals LP.
EPKINLY® (Epcoritamab-bysp)
The FDA on May 19, 2023 granted accelerated approval to EPKINLY® for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. EPKINLY® is a product of Genmab US, Inc.
POLIVY® (Polatuzumab vedotin-piiq)
The FDA on April 19, 2023, approved POLIVY® with a Rituximab product, Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) for adult patients who have previously untreated Diffuse Large B-Cell Lymphoma (DLBCL), not otherwise specified (NOS), or High-Grade B-Cell Lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of 2 or greater. POLIVY® is a product of Genentech, Inc.
OMISIRGE® (Omidubicel-onlv)
The FDA on April 17, 2023, approved OMISIRGE® for use in adult and pediatric patients (12 years and older) with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning, to reduce the time to neutrophil recovery and the incidence of infection. OMISIRGE® is a product of Gamida Cell Ltd.
PADCEV® (Enfortumab vedotin-ejfv) with KEYTRUDA® (Pembrolizumab)
The FDA on April 3, 2023, granted accelerated approval to PADCEV® with KEYTRUDA® for patients with locally advanced or metastatic Urothelial Carcinoma who are ineligible for Cisplatin-containing chemotherapy. PADCEV® is a product of Astellas Pharma and KEYTRUDA® is a product of Merck.
ZYNYZ® (Retifanlimab-dlwr)
The FDA on March 22, 2023, granted accelerated approval to ZYNYZ® for adult patients with metastatic or recurrent locally advanced Merkel Cell Carcinoma (MCC). ZYNYZ® is a product of Incyte Corporation.
TAFINLAR® (Dabrafenib) and MEKINIST® (Trametinib)
The FDA on March 16, 2023, approved TAFINLAR® with MEKINIST® for pediatric patients 1 year of age and older with Low-Grade Glioma (LGG) with a BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formulations of both drugs suitable for patients who cannot swallow pills. TAFINLAR® and MEKINIST® are products of Novartis.