FDA Approvals, News & Updates

In ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer, malignant cells form in the tissue covering the ovary or lining the fallopian tube or peritoneum. According to the American Cancer Society, in 2017 more than 22,000 women in the United States were estimated to be diagnosed with these cancers and more than 14,000 to die from them.
  • Enasidenib, a New Targeted Therapy Approved for Relapsed or Refractory AML, Shows Complete Remission in Some Patients
  • Ibrutinib First Treatment Approved by the FDA for Chronic Graft-versus-Host Disease
  • Vyxeos First Treatment Approved Specifically for 2 Types of High-Risk AML
  • First CAR T-Cell Therapy Unanimously Recommended by FDA Advisory Committee for Treatment of B-Cell ALL in Children and Young Adults
HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan.
On July 11, 2017, the FDA approved an expanded indication for blinatumomab (Blincyto; Amgen) to include the treatment of patients with Philadelphia chromosome (Ph)-positive (Ph+), relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
On June 29, 2017, the FDA authorized the marketing of ClearLLab Reagents (from Beckman Coulter, Inc), the first test that is agency approved to aid flow cytometry in the marking and detecting of several blood cancers
On July 12, 2017, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended the approval of Novartis’s CTL019 (tisagenlecleucel)—the first ever chimeric antigen receptor (CAR) T-cell therapy to be presented to the FDA for review for the treatment of pediatric patients and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).
On June 16, 2017, the FDA approved daratumumab (Darzalex; Janssen Biotech), in combination with pomalidomide (Pomalyst) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 2 previous therapies, including lenalidomide (Rev­limid) and a proteasome inhibitor.
On May 23, 2017, the FDA granted accelerated approval to pembrolizumab (Keytruda; Merck) for the treatment of metastatic, microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) solid tumors that have progressed after previous treatment and have no appropriate alternative treatments, or for colorectal cancer that has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
On May 1, 2017, the FDA accelerated the approval of durvalumab (Imfinzi; AstraZeneca) for the treatment of locally advanced or metastatic urothelial carcinoma in patients whose disease progressed during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment.
On April 28, 2017, the FDA approved brigatinib (Alunbrig; Takeda), an oral kinase inhibitor, for the treatment of patients with metastatic non–small-cell lung cancer (NSCLC) with ALK mutation whose disease progressed during crizotinib therapy or who are intolerant to crizotinib therapy.
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