The FDA on December 4, 2024, approved IMFINZI® for adults with Limited-Stage Small Cell Lung Cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. IMFINZI® is a product of AstraZeneca.
Category: FDA Approvals
BIZENGRI® (Zenocutuzumab-zbco)
The FDA on December 4, 2024, granted accelerated approval to BIZENGRI® for adults with the following:
Advanced, unresectable, or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring a Neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or
Advanced, unresectable, or metastatic Pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy.
BIZENGRI® is a product of Merus N.V.
ZIIHERA® (Zanidatamab-hrii)
The FDA on November 20, 2024, granted accelerated approval to ZIIHERA®, a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. ZIIHERA® is a product of Jazz Pharmaceuticals, Inc.
REVUFORJ® (Revumenib)
The FDA on November 15, 2024, approved REVUFORJ®, a menin inhibitor, for Relapsed or Refractory Acute Leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older. REVUFORJ® is a product of Syndax Pharmaceuticals, Inc.
AUCATZYL® (Obecabtagene autoleucel)
The FDA on November 8, 2024, approved AUCATZYL®, a CD19-directed genetically modified autologous T cell immunotherapy, for adults with Relapsed or Refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL). AUCATZYL® is a product of Autolus Inc.
SCEMBLIX® (Asciminib)
The FDA on October 29, 2024, granted accelerated approval to SCEMBLIX® (Asciminib) for adult patients with newly diagnosed Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML) in Chronic Phase (CP). SCEMBLIX® is a product of Novartis AG.
VYLOY® (Zolbetuximab-clzb)
The FDA on October 18, 2024, approved VYLOY®, a Claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with Fluoropyrimidine- and Platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic Human Epidermal growth factor Receptor 2 (HER2)-negative Gastric or GastroEsophageal Junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test. VYLOY® is a product of Astellas Pharma US, Inc.
ITOVEBI® (Inavolisib)
The FDA on October 10, 2024, approved ITOVEBI® with Palbociclib and Fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, Human Epidermal growth-factor Receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. ITOVEBI® is a product of Genentech, Inc.
OPDIVO® (Nivolumab)
The FDA on October 3, 2024, approved OPDIVO® with Platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent OPDIVO® after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) Non-Small Cell Lung Cancer (NSCLC) and no known Epidermal Growth Factor Receptor (EGFR) mutations or Anaplastic Lymphoma Kinase (ALK) rearrangements. OPDIVO® is a product of Bristol Myers Squibb Company.
RETEVMO® (Selpercatinib)
The FDA on September 27, 2024, granted traditional approval to RETEVMO® for adult and pediatric patients 2 years of age and older with advanced or metastatic Medullary Thyroid Cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. RETEVMO® is a product of Eli Lilly and Company.