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FDA Approvals

On June 10, 2019, the FDA accelerated the approval of polatuzumab vedotin-piiq (Polivy; Genentech), a CD79b-directed antibody-drug conjugate, in combination with bendamustine (Bendeka, Treanda) plus rituximab (Rituxan or a biosimilar; BR) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after ≥2 previous therapies.
On July 3, 2019, the FDA granted accelerated approval to selinexor (Xpovio; Karyopharm Therapeutics), a nuclear export inhibitor, in combination with dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma (MM) who had received ≥4 previous therapies and whose disease is resistant to several other forms of treatment, including ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and an anti-CD38 monoclonal antibody.
This section provides a brief overview of new cancer drugs or new indications approved by the FDA between June 10 and July 3, 2019.
Lung cancer is the second most frequently diagnosed malignancy in both men and women (following prostate and breast cancer, respectively), and the leading cause of cancer deaths overall. Non–small-cell lung cancer (NSCLC) is the most common type, with the more aggressive small-cell lung cancer (SCLC) making up approximately 10% to 15% of cases.
On June 10, 2019, the US Food and Drug Administration (FDA) granted accelerated approval to the novel antibody-drug conjugate polatuzumab vedotin-piiq (Polivy; Genentech) in combination with bendamustine plus rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least 2 previous therapies. This is the first chemoimmunotherapy regimen approved for use in patients with DLBCL who are ineligible for hematopoietic stem-cell transplantation.
The Lynx Group is pleased to bring you the Fourth Annual Oncology Guide to New FDA Approvals. The goal of this Guide is to offer oncologists, pharmacists, oncology nurses, and other healthcare stakeholders a comprehensive overview of new drugs approved by the US Food and Drug administration (FDA) in 2018 for the treatment of different types of cancer, including hematologic and oncologic malignancies. This practical tool offers a quick, evidence-based resource for hematology/oncology professionals to guide their medication-related decision-making and help ensure the administration of recent medicines for appropriate patients.
  • Introduction
  • Oncology Overview
  • Breast Cancer New Indications
  • Genitourinary Cancers New Indications
  • Gynecologic Cancers New Indications
  • Hematologic Malignancies New Indications
  • Lung Cancer New Indications
  • Other Tumor Types New Indications
  1. New Molecular Entities and New Biologic License Applications
  2. New Oncology Biosimilars Approved in 2018
Melanoma is the most dangerous form of skin cancer.1 The 5-year relative survival rate for Americans with distant melanoma is only 23%. The National Cancer Institute estimated that there were 91,270 new cases of skin melanoma and more than 9300 deaths from this disease in 2018. This deadly disease is also costly; in the United States, expenditures for the treatment of melanoma exceeded $3 billion in 2018.
Chronic lymphocytic leukemia (CLL) is a cancer of B-cell lymphocytes and is the most common type of leukemia in adults. More than 20,000 Americans were diagnosed with CLL in 2018.
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