The FDA on September 17, 2024, approved KISQALI® with an Aromatase Inhibitor for the adjuvant treatment of adults with Hormone Receptor (HR)-positive, human Epidermal Growth Factor Receptor 2 (HER2)-negative Stage II and III early Breast cancer at high risk of recurrence. Additionally, FDA also approved the KISQALI® and FEMARA® Co-Pack for the same indication. KISQALI® and KISQALI® FEMARA® Co-Pack are products of Novartis Pharmaceuticals Corporation.
Author: RR
TECENTRIQ HYBREZA® (Atezolizumab and hyaluronidase-tqjs)
The FDA on September 12, 2024, approved TECENTRIQ HYBREZA® for subcutaneous injection for all the adult indications as the intravenous formulation of TECENTRIQ®, including Non-Small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC), HepatoCellular Carcinoma (HCC), Melanoma, and Alveolar Soft Part Sarcoma (ASPS). Both TECENTRIQ® and TECENTRIQ HYBREZA® are products of Genentech, Inc.
LAZCLUZE® (Lazertinib) plus RYBREVANT® (amivantamab-vmjw)
The FDA on August 19, 2024, approved LAZCLUZE® in combination with RYBREVANT® for the first-line treatment of 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, as detected by an FDA-approved test. Both LAZCLUZE® and RYBREVANT® are products of Janssen Biotech, Inc.
IMFINZI® (Durvalumab)
The FDA on August 15, 2024, approved IMFINZI® with Platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent IMFINZI® as adjuvant treatment after surgery 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. IMFINZI® is a product of AstraZeneca.
NIKTIMVO® (axatilimab-csfr)
The FDA on August 14, 2024, approved NIKTIMVO®, a colony stimulating factor-1 receptor-blocking antibody, for the treatment of chronic Graft-Versus-Host Disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. NIKTIMVO® is a product of Incyte Corporation.
VORANIGO® (Vorasidenib)
The FDA on August 6, 2024, approved VORANIGO®, an Isocitrate DeHydrogenase-1 (IDH1) and Isocitrate DeHydrogenase-2 (IDH2) inhibitor, for adult and pediatric patients 12 years and older with Grade 2 Astrocytoma or Oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following surgery including biopsy, sub-total resection, or gross total resection. VORANIGO® is a product of Servier Pharmaceuticals, LLC.
TECELRA® (afamitresgene autoleucel)
The FDA on August 2, 2024, granted accelerated approval to TECELRA®, a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. TECELRA® is a product of Adaptimmune, LLC.
JEMPERLI® (Dostarlimab-gxly)
The FDA on August 1, 2024, approved JEMPERLI® with Carboplatin and Paclitaxel, followed by single-agent JEMPERLI®, for adult patients with primary advanced or recurrent Endometrial cancer. JEMPERLI® is a product of GSK.
DARZALEX FASPRO® (Daratumumab and hyaluronidase-fihj)
The FDA on July 30, 2024, approved DARZALEX FASPRO® in combination with Bortezomib, Lenalidomide, and Dexamethasone for induction and consolidation in patients with newly diagnosed Multiple Myeloma who are eligible for Autologous Stem Cell Transplant (ASCT). DARZALEX FASPRO® is a product of Janssen Research & Development, LLC.
EPKINLY® (Epcoritamab-bysp)
The FDA on June 26, 2024, granted accelerated approval to EPKINLY®, a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory Follicular Lymphoma (FL) after two or more lines of systemic therapy. EPKINLY® is a product of Genmab US, Inc.