FDA Approvals, News & Updates

The first blood test for detecting epidermal growth factor receptor (EGFR) gene mutations in patients with non−small-cell lung cancer (NSCLC) has been approved by the US Food and Drug Administration. The cobas EGFR Mutation Test v2 is a blood-based diagnostic that aids in selecting patients with NSCLC who may benefit from treatment with erlotinib (Tarceva).
Atezolizumab injection (Tecentriq) has been approved by the US Food and Drug Administration for patients with locally advanced or metastatic urothelial carcinoma with disease progression after or ≤12 months of receiving platinum-containing chemotherapy. The recommended dosage of the drug, which is programmed death-ligand 1 blocking antibody, is 1200 mg administered intravenously every 3 weeks until disease progression or unacceptable toxicity.
The US Food and Drug Administration has approved nivolumab (Opdivo) for patients with classical Hodgkin Lymphoma that has progressed or relapsed following autologous hematopoietic stem cell transplantation and post-transplant brentuximab vedotin, according to an announcement by the agency. Notably, the intravenous drug was granted accelerated approval, and Breakthrough Therapy Designation.
Lenvatinib capsules (Lenvima) have been approved in combination with everolimus in patients with advanced renal cell carcinoma who have had 1 previous anti-angiogenic therapy, according to an announcement by the US Food and Drug Administration. The combination has demonstrated greater progression-free and overall survival rates, compared with lenvatinib monotherapy.
  • FDA Approves First and Only Blood-Based Colorectal Cancer Screening Test
  • Imbruvica Now FDA Approved for First-Line Treatment of Patients with CLL
  • Gazyva Approved for the Treatment of Relapsed or Refractory Follicular Lymphoma
  • Ibrance Receives an Expanded Indication in Breast Cancer
  • Kyprolis Receives New Indication for Relapsed or Refractory Multiple Myeloma
  • Venclexta First BCL-2 Targeted Drug Approved for Patients with CLL plus 17p Deletion
  • FDA Approves First and Only Blood-Based Colorectal Cancer Screening Test
  • Imbruvica Now FDA Approved for First-Line Treatment of Patients with CLL
  • Gazyva Approved for the Treatment of Relapsed or Refractory Follicular Lymphoma
  • Ibrance Receives an Expanded Indication in Breast Cancer
  • Kyprolis Receives New Indication for Relapsed or Refractory Multiple Myeloma
  • FDA Grants Priority Review for Venetoclax as a Potential New Treatment for CLL
Venetoclax (Venclexta) has been approved by the US Food and Drug Administration (FDA) for daily use in patients with chronic lymphocytic leukemia (CLL) who have 17p deletion, and had ≥1 prior therapies, according to an announcement by the agency. This drug is the first treatment that targets the B-cell lymphoma 2 protein, which is overexpressed in many patients with CLL.
Defibrotide sodium (Defitelio) is now US Food and Drug Administration (FDA)-approved for children and adult patients with hepatic veno-occlusive disease (VOD) with added kidney or lung abnormalities following hematopoietic stem cell transplantation (HSCT). This drug is the first to be approved for patients with severe hepatic VOD.
Immediate-release opioid analgesics will now require boxed warnings regarding the serious risks for abuse, addiction, overdose, neonatal opioid withdrawal syndrome (NOWS), and death associated with the drugs, according to an announcement by the US Food and Drug Administration (FDA).
Crizotinib (Xalkori) has been approved for expanded use in patients with metastatic non−small-cell lung cancer (NSCLC) whose tumors have an ROS1 gene alteration, according to an announcement by the US Food and Drug Administration (FDA). The first and only approved treatment for this patient population, crizotinib blocks ROS1 protein activity in tumors, possibly preventing NSCLC from spreading.
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