publication date: Jan. 3, 2020
Issue 1 - Jan. 3, 2020
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  • FDA guidance restricts e-cigarette flavors, leaving tobacco and menthol on the market

    FDA Jan. 2 issued a final guidance that will restrict the sale of e-cigarette flavors most popular with minors.

  • Guest Editorial

    FDA e-cigarette flavoring ban leaves a bad taste

    “TRUMP ERODING ROLE OF SCIENCE IN GOVERNMENT” 

    The ink hadn’t dried on the headline of the lead story in the Dec. 29 issue of The New York Times when on Jan. 2 HHS Secretary Alex Azar and newly arrived FDA Commissioner Stephen M. Hahn made the following announcement:

  • Pazdur on the challenge of approving drugs for small indications

    ODAC recommends approval for tazemetostat in rare sarcoma, sNDAs for Lynparza, Keytruda

    The FDA Oncologic Drugs Advisory Committee in a session Dec. 17 and 18 considered three applications that were arranged thematically, to show how the agency is approaching indications where the number of patients is small and the disease catastrophic.

  • Moffitt CEO Alan List, director Thomas Sellers resign over conflicts of interests involving China

    Thomas Sellers, director of Moffitt Cancer Center, and Alan List, president and CEO of the center, stepped down Dec. 18 after an internal review revealed that they violated “conflict of interest rules through their work in China,” cancer center officials said.

  • Trump approves $212.5M increase to improve NCI success rates; FY20 spending bills provide new funding for childhood cancer, raise tobacco-purchase age to 21

    President Donald Trump signed $1.4 trillion in spending bills Dec. 20 that includes a $212.5 million increase for NCI to cope with an avalanche of grant applications and improve the institute’s declining success rates.

  • Fox Chase acquired by Jefferson in definitive agreement with Temple

    Thomas Jefferson University and Temple University Dec. 18 entered into a binding definitive agreement for Jefferson’s acquisition of Fox Chase Cancer Center and Temple’s Bone Marrow Transplant Program.

  • In Brief

    • HHS proposes plan to import cheaper drugs from Canada
    • Vokes elected ASCO president for 2021-22
    • Hahn sworn in as FDA commissioner
    • Fred Hutch receives $13M SPORE for immunotherapy, lung cancer research
    • Mt. Sinai receives $10M in NIH funding for brain tumor research
    • Ten oncology practices in underserved communities receive ASCO funding to participate in quality improvement programs
    • PharmaMar and Jazz Pharmaceuticals sign license agreement for lurbinectedin in U.S.
  • TCCL Logo

  • Clinical Roundup

    • NCCN pediatric cancer guidelines focus on improving long-term outcomes worldwide
    • SWOG study focuses on impact of vitamin and antioxidant supplement use in cancer patients
    • DREAMM-2 demonstrates meaningful ORR with belantamab mafodotin in multiple myeloma
  • Drugs & Targets

    • FDA approves Lynparza as first-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer
    • FDA approves Xtandi for metastatic castration-sensitive prostate indication
    • FDA approves treatment for patients with HER2-positive breast cancer who have progressed on available therapies
    • FDA grants accelerated approval to enfortumab vedotin-ejfv for metastatic urothelial cancer
    • FDA grants Avatrombopag Orphan Drug Designation for chemotherapy-induced thrombocytopenia
    • Karyopharm submits NDA for Xpovio for relapsed or refractory diffuse large B-cell lymphoma
    • Amgen and Allergan submit BLA for biosimilar candidate to Rituxan
    • China approves Zejula as maintenance therapy for recurrent ovarian cancer

Copyright (c) 2020 The Cancer Letter Inc.