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.
Category: FDA Approvals
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.
KEYTRUDA® (Pembrolizumab)
The FDA on September 17, 2024, approved KEYTRUDA® with Pemetrexed and Platinum chemotherapy as first-line treatment of unresectable advanced or metastatic Malignant Pleural Mesothelioma (MPM). KEYTRUDA® is a product of Merck & Co., Inc.
KISQALI® (Ribociclib)
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.
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.