FDA News & Updates

• Fluciclovine F18 Diagnostic Imaging Agent Approved to Detect Recurrent Prostate Cancer
• Tecentriq for Metastatic Urothelial Bladder Cancer
• Afatinib Receives New Indication for Advanced Squamous-Cell NSCLC
• FDA Approves Netspot Diagnostic Test to Detect Neuroendocrine Tumors

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Daclizumab (Zinbryta) has been approved by the US Food and Drug Administration for adults with relapsing forms of multiple sclerosis. The drug is self-administered by the patient monthly, and comes in the form of a long-acting injection. Read More ›

The US Food and Drug Administration has approved Netspot, the first kit for preparation of gallium Ga 68 dotatate injection, for the detection of neuroendocrine tumors in adult and pediatric patients. The injection serves as a radioactive diagnostic agent for positron emission tomography imaging. Read More ›

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). Read More ›

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. Read More ›

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. Read More ›

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. Read More ›

• 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

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The drugs included in this review were approved by the US Food and Drug Administration (FDA) in 2015 and are grouped into the following categories. Read More ›