publication date: Nov. 11, 2016
Issue 42 - Nov. 11, 2016
  • Conversation with The Cancer Letter

    FDA Eager to Approve PD-1 and PD-L1 Drugs in Novel Combinations, New Settings

    In an in-depth interview with The Cancer Letter, an FDA official clarified the agency’s criteria for approval of drugs that target PD-1 and PD-L1.

    Last month, The Cancer Letter reported that there are 803 registered clinical trials testing 20 PD-1 and PD-L1 drugs. These trials have slots for 166,736 patients. (The Cancer Letter, Oct. 7).

    The scope of this development effort appears to be unprecedented.

  • What the Trump Presidency Means for Cancer Care, the ACA, and the Moonshot

    President Barack Obama’s legacy health care programs—the Affordable Care Act, and the National Cancer Moonshot Initiative—have been thrown into uncertainty.

    Hours after Republican Donald Trump became president-elect of the United States, Washington is left in a muddle: hopeful Democratic appointees who expected to join Hillary Clinton’s ranks ended up empty-handed. At stake is leadership at federal agencies, including the HHS, NIH, NCI, and FDA.

  • Fred Hutchinson Opens Cellular Immunotherapy Clinic

    Fred Hutchinson Cancer Research Center has opened a first-of-its-kind clinic focused on cellular-based immunotherapies for cancer patients in clinical trials.

    The Bezos Family Immunotherapy Clinic will allow researchers to conduct twice as many immunotherapy trials in the next year in pursuit of speeding cures for cancer, officials said.

  • In Brief

    • Peter O’Dwyer elected group co-chair elect of the ECOG-ACRIN
    • Charles Drake joins NY-Presbyterian/Columbia as director of genitourinary oncology. associate director at the Columbia Cancer Center, co-director immunotherapy program.
    • William Cance joins University of Arizona Cancer Center as deputy director
    • Craig Reynolds to retire as as director of the NCI Office of Scientific Operations at Frederick
    • Elisabeth Heath, of Karmanos, receives the Michigan Cancer Consortium’s inaugural Champion Award
    • Felipe Suero joins Department of Anesthesiology at Fox Chase
    • Valierie Armstead joins Fox Chase Cancer Center as professor in anesthesiology
    • Susan Rawl, of Indiana University School of Nursing and IU Cancer Center, receives $2.6M from PCORI for colorectal cancer screening research
    • IU School of Nursing establishes Champion Center for Cancer Control Research, named after Distinguished Professor Victoria Champion.
    • NCCN launches Just Bag It campaign for safe handling of vincristine 
    • Weill Cornell Medicine and New York Genome Center receive a NCI grant worth $490,000-a-year five-year grant for joint cancer genomics data center
    • John Wayne Cancer Institute and Singapore’s Clearbridge BioMedics to establish a circulating tumor cell center
    • St. Baldrick’s Foundation provides infrastructure grants to nearly 40 childhood cancer institutions
  • Drugs and Targets

    • Opdivo receives FDA approval for recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy
    • Amgen and Janssen Biotech to evaluate combination of Amgen’s Kyprolis and Janssen’s Darzalex in multiple clinical studies in multiple myeloma
    • Hopkins and BMS announce five-year collaboration to study resistance to checkpoint blockers and develop combination immunotherapies.
    • Mylan and Biocon submit BLA for biosimilar trastuzumab
    • FDA has accepts Genentech’s BLA for a subcutaneous formulation of rituximab in blood cancer indications
    • LEE011, Novartis’s selective cyclin dependent kinase inhibitor, granted FDA Priority Review
    • Verastem licenses exclusive worldwide rights to develop and commercialize Infinity’s oncology product candidate duvelisib.
    • VENTANA ALK (D5F3) CDx gets FDA approval to use on the VENTANA BenchMark ULTRA automated slide stainer
  • Funding Opportunities

    • SU2C and Genentech form “Catalyst” to provide research funding and access to compounds in effort to find new indications
    • SU2C makes $7.5 million in grants available to early-career scientists focusing on immuno-oncology

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