FDA Approvals, News & Updates

November 11, 2019 — Oncology News & Updates

  • FDA Approves Ziextenzo, Third Biosimilar to Pegfilgrastim for Febrile Neutropenia
  • Trump Will Nominate Dr Hahn as Next FDA Commissioner
  • Researchers Report High Rates of E-Cigarette Use Among Children and Teens

October 28, 2019 – Oncology News & Updates

In This Article Zejula Now Approved for Late-Line Ovarian Cancer Trump Set to Nominate Hahn as FDA Commissioner FDA Aims to Improve Breast Implant Guidance Zejula Now Approved for Late-Line Ovarian Cancer On October 23, 2019, the FDA approved niraparib (Zejula; Tesaro), a poly (ADP-ribose) polymerase inhibitor, for the treatment [ Read More ]

Vincristine, Racial Disparities in Multiple Myeloma, and HER2 Metastatic Breast Cancer Are in the News

In This Article Critical Shortage of Pediatric Cancer Drug Leads to Serious Concerns Study Finds Racial Disparities in Multiple Myeloma Treatment FDA Grants Priority Review to Trastuzumab Deruxtecan for HER2-Positive Metastatic Breast Cancer The past week in oncology-related news includes shortages of crucial pediatric cancer drug, results of a study [ Read More ]

Keytruda Approved for Patients with Previously Treated Metastatic Small-Cell Lung Cancer

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 [ Read More ]

First Chemoimmunotherapy Regimen Granted Accelerated Approval for Patients with Previously Treated DLBCL

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 [ Read More ]

FDA Expands Indication for Kadcyla to Include the Adjuvant Treatment of HER2-Positive Early Breast Cancer

On May 3, 2019, the US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected for treatment with this agent based on an [ Read More ]

Ivosidenib Now FDA-Approved as First-Line Treatment for AML with IDH1 Mutation

On May 2, 2019, the US Food and Drug Administration (FDA) approved ivosidenib (Tibsovo; Agios Pharmaceuticals, Inc) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved companion diagnostic test, in patients who are aged ≥75 years or who have [ Read More ]

FDA Approves Pembrolizumab plus Axitinib for Advanced Renal-Cell Carcinoma

On April 19, 2019, the US Food and Drug Administration (FDA) approved a combination of pembrolizumab (Keytruda; Merck) plus axitinib (Inlyta; Pfizer) for the first-line treatment of patients with advanced renal-cell carcinoma (RCC), making it the first immunotherapy combination regimen approved for patients with this disease. This application was granted [ Read More ]

April 16, 2019 – FDA Approvals, News & Updates

In This Article FDA Approves Keytruda for First-Line Treatment of Non–Small-Cell Lung Cancer (TPS ≥1%) FDA Advises Women to Avoid Pregnancy for Only 2 Months After Final Dose of Soltamox FDA Approves Keytruda for First-Line Treatment of Non–Small-Cell Lung Cancer (TPS ≥1%) On April 11, 2019, the US Food and [ Read More ]

FDA Approves First Hormonal-Based Therapy for Men with Advanced or Metastatic Breast Cancer

On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based [ Read More ]

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