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.
Category: FDA Approvals
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.
VERZENIO® (Abemaciclib)
The FDA on March 3, 2023, approved VERZENIO® with endocrine therapy (Tamoxifen or an Aromatase Inhibitor) for the adjuvant treatment of adult patients with Hormone Receptor (HR)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. VERZENIO® is a product of Eli Lilly and Company.
JEMPERLI® (Dostarlimab-gxly)
The FDA on February 9, 2023, approved JEMPERLI® for adult patients with MisMatch Repair deficient (dMMR) recurrent or advanced Endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. JEMPERLI® is a product of GlaxoSmithKline LLC.
TRODELVY® (Sacituzumab Govitecan-hziy)
The FDA on February 3, 2023, approved TRODELVY® for unresectable locally advanced or metastatic Hormone Receptor (HR)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. TRODELVY® is a product of Gilead Sciences, Inc.