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FDA News & Updates

The US Food and Drug Administration (FDA) announced the approval of Inflectra (infliximab-dyyb)—a biosimilar to Remicade (infliximab)—for patients with chronic severe plaque psoriasis, and active ankylosing spondylitis or psoriatic arthritis. The biosimilar is also indicated for adult patients with moderately to severely active ulcerative colitis who have inadequately responded to standard therapy; in combination with methotrexate for patients with moderately to severely active rheumatoid arthritis; and patients aged ≥6 years with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Inflectra is the second biosimilar approved by the FDA.
The U.S. Food and Drug Administration today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib).
The U.S. Food and Drug Administration today approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.
Today the U.S. Food and Drug Administration granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma.
Today the U.S. Food and Drug Administration granted approval for Ninlaro (ixazomib) in combination with two other therapies to treat people with multiple myeloma who have received at least one prior therapy.
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.
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).
  • 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
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.
  • 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
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