FDA Approvals, News & Updates

Today, the US Food and Drug Administration (FDA) granted accelerated approval for an oral medication to treat patients with advanced non—small-cell lung cancer (NSCLC). Tagrisso (osimertinib) is now approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy. Read More ›

The US Food and Drug Administration (FDA) today approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation). Read More ›

  • Gefitinib Approved for First-Line Treatment of Metastatic Lung Cancer Associated with EGFR Mutations
  • Sonidegib Approved for Locally Advanced Basal-Cell Carcinoma
  • Brentuximab Vedotin Gets New Indication for Patients with Hodgkin Lymphoma
  • Emend Gets Expanded Indication for CINV Prevention in Pediatric Patients
  • Rolapitant a New Antiemetic Option for CINV Prevention
  • Lonsurf a New Oral Combination for Patients with Metastatic Colorectal Cancer
  • First Combination of 2 Immunotherapies Approved for Advanced Melanoma
  • Keytruda, plus a Companion Diagnostic, Approved for Metastatic Lung Cancer
Read More ›

The US Food and Drug Administration (FDA) is hoping that its December 4, 2014, final rule on pregnancy and breastfeeding labeling for prescription drugs and biological products1 will be helpful to patients and providers. Clinicians are also optimistic about the changes but are waiting to see whether sufficient data will be available to truly clarify the risks of using each medication during conception, pregnancy, and lactation. Read More ›

  • Jakafi Gets New Indication for Use in Patients with Polycythemia Vera
  • Cyramza Approved in Combination with Docetaxel for Metastatic NSCLC
  • Blincyto First Immunotherapy Approved for B-Cell Acute Lymphoblastic Leukemia
  • Avastin plus Chemotherapy for Platinum-Resistant Gynecologic Cancers
  • FDA Approves Nivolumab for Advanced Melanoma
Read More ›

FDA Approves First Anti–PD-1: Pembrolizumab Indicated for Advanced Melanoma
Bortezomib Receives New FDA Indication Read More ›

The challenges involved with the start of implementation of the Affordable Care Act (ACA)’s insurance exchange program are evident in the responses to an April 2014 survey by the Medical Group Management Association (MGMA). Read More ›

On April 29, 2014, the US Food and Drug Administration (FDA) approved ceritinib (Zykadia; Novartis) for the treatment of patients with metastatic, anaplastic lymphoma kinase (ALK)-positive non–small-cell lung cancer (NSCLC). Read More ›

As oncology practice managers assume higher levels of assistance to the medical oncology staff, it becomes critically important to stay abreast of the latest news and updates concerning the drug agents used in cancer treatment. Read More ›

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