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.
Category: FDA Approvals
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.
TAGRISSO® (Osimertinib)
The FDA on September 25, 2024, approved TAGRISSO® for adult patients with locally advanced, unresectable (Stage III) Non-Small Cell Lung Cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential Platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. TAGRISSO® is a product of AstraZeneca Pharmaceuticals.
SARCLISA® (Isatuximab-irfc)
The FDA on September 20, 2024, approved SARCLISA® with Bortezomib, Lenalidomide, and Dexamethasone for adults with newly diagnosed Multiple Myeloma who are not eligible for Autologous Stem Cell Transplant (ASCT). SARCLISA® is a product of Sanofi-Aventis U.S., LLC.
RYBREVANT® (amivantamab-vmjw)
The FDA on September 19, 2024, approved RYBREVANT® with Carboplatin and Pemetrexed for adult patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. RYBREVANT® is a product of Janssen Biotech, Inc.