FDA / Drug Updates

FDA News – June 2017

June 2017, Vol 8, No 3 - FDA News & Updates

  • Keytruda First Cancer Drug Approved for Any Solid Tumor Based on a Biomarker Instead of Tumor Site
  • Imfinzi a New PD-L1 Approved for Bladder Cancer After Platinum-Based Chemotherapy
  • Alunbrig, an Oral Kinase Inhibitor, Receives FDA Approval for NSCLC with ALK Mutation
  • Rydapt First Drug in Decades Approved by the FDA for Acute Myeloid Leukemia
  • Stivarga First Drug in a Decade Approved by the FDA for Liver Cancer
  • Atezolizumab Approved as First-Line Treatment for Advanced Bladder Cancer in Some Patients
  • Tagrisso Receives Full Approval for NSCLC with EGFR T790M Mutation
  • Zejula a New Maintenance Treatment Option for Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
  • Bavencio, a PD-L1 Inhibitor, First Nonchemotherapy Drug Approved for Merkel-Cell Carcinoma
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FDA News – April 2017

April 2017, Vol 8, No 2 - FDA News & Updates

  • Keytruda Receives Accelerated Approval for Relapsed/Refractory Classical Hodgkin Lymphoma
  • Kisqali, a New CDK4/CDK6 Inhibitor, Approved for First-Line Therapy in HR-Positive, HER2-Negative Advanced Breast Cancer
  • Xermelo First Oral Treatment Approved for Carcinoid Syndrome Diarrhea in Patients with NETs
  • Revlimid Receives New Indication for Maintenance Therapy in Multiple Myeloma After Autologous Stem-Cell Transplant
  • Opdivo a New Option for Advanced or Metastatic Bladder Cancer
  • Imbruvica First Nonchemotherapy Drug Approved for Relapsed/Refractory Marginal Zone Lymphoma
  • Rubraca Receives Accelerated Approval for Advanced Ovarian Cancer
  • Zejula a New Option for Maintenance Treatment of Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
[ Read More ]

FDA News – November 2016

November 2016, Vol 7, No 10 - FDA News & Updates

  • Tecentriq Approved by the FDA for Metastatic NSCLC
  • Keytruda Receives New FDA Indication for First-Line Treatment of Metastatic NSCLC
  • Lartruvo First Drug in 40 Years to Receive FDA Approval for Soft-Tissue Sarcoma
  • FDA Revises the Indication for Tarceva for Treatment of NSCLC
  • FDA Awards $23 Million Worth of Grants to Encourage Drug Development for Rare Diseases
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FDA News – October 2016

October 2016, Vol 7, No 9 - FDA News & Updates

In This Article Dosage Regimen for Nivolumab Modified Use of Screening Tests for Ovarian Cancer Not Supported by the FDA Dosage Regimen for Nivolumab Modified On September 13, 2016, the FDA modified the dosage regimen of nivolumab (Opdivo) for the treatment of patients with renal-cell carcinoma, metastatic melanoma, and non–small-cell lung cancer (NSCLC) to 240 mg intravenously (IV) every [ Read More ]

Tecentriq (Atezolizumab) First PD-L1 Inhibitor Approved for Patients with Advanced or Metastatic Urothelial Carcinoma

Lisa A. Raedler, PhD, RPh

September 2016, Vol 7, No 8 - Drug Updates

Urothelial carcinoma (also known as transitional-cell carcinoma) is the most common subtype of bladder cancer, accounting for more than 90% of bladder cancer diagnoses in the United States. In 2016, nearly 77,000 cases of bladder cancer are expected to be diagnosed in the United States, and more than 16,000 people will die from this disease. The incidence of bladder cancer increases with age, with a median age of 73 years at diagnosis. [ Read More ]