Issue 1 - Jan 3, 2020
  • 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.
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  • 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
Issue 46 - Dec 13, 2019
  • “Call me Doctor”

    How women in oncology are fighting for cultural change

    A sense of foreboding descended on Narjust Duma as she sat at a presentation on drug-induced toxicities. The year was 2018, Duma was a 31-year-old second-year fellow at Mayo Clinic, and her discomfort stemmed from something other than the subject matter discussed.

  • Don’t call me Karen, Cheryl, Nancy, Reshma, Cornelia, Caryn, Sharon, … call me “Doctor.”

    Seven prominent women leaders in oncology—Karen Knudsen, Cheryl Willman, Reshma Jagsi, Nancy Davidson, Cornelia Ulrich, Caryn Lerman, and Sharon Stack—spoke with The Cancer Letter about their experiences with gender bias, implicit and explicit.

  • In Brief

    • Senate confirms Stephen Hahn as FDA commissioner
    • Moderate levels of alcohol consumption linked to higher risk of some cancers, NCI writes in JAMA
    • MSK to open David H. Koch Center for Cancer Care in January 2020
    • Thomas Jefferson University receives $70 million for new biomedical research building
    • Edmondo Robinson named chief digital innovation officer at Moffitt
    • Winship realigns its research programs to increase impact
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  • Trials & Tribulations

    Nobel Prize Award: Impact of Clinical Care?

    On December 10, 2019, Dr. William G. Kaelin, Jr, Sir Peter J. Ratcliffe, and Dr. Gregg L. Semenza officially received the title of Nobel Laureate in Medicine.

  • Clinical Roundup

    • PD-1 inhibitor treatment prior to stem cell transplant is safe, effective in classic Hodgkin lymphoma
    • BMS’s liso-cel met primary, secondary endpoints in TRANSCEND NHL 001
    • Phase II KarMMa study of ide-cel in relapsed, refractory multiple myeloma meets ORR primary endpoint
    • Seattle Genetics announces positive OS, PFS, ORR for tucatinib in HER2+ breast cancer
    • ctDNA may help predict recurrence in patient with early triple-negative breast cancer
    • Extended follow-up phase III data underscore sustained efficacy and safety of Imbruvica in CLL
    • Phase III TOURMALINE-AL1 trial of Ninlaro in patients with amyloidosis didn’t meet one of two primary endpoints
    • Phase III SOPHIA study shows margetuximab didn’t reach significance for OS in HER2+ metastatic breast cancer
    • Keytruda improved OS in frontline metastatic NSCLC regardless of KRAS status
    • Venetoclax in reduced-intensity transplant conditioning regimen in high-risk myeloid cancers shows promise
  • Drugs & Targets

    • FDA issues draft guidance to foster pediatric oncology product development
    • FDA approves Avsola for same indications as Remicade
    • FDA grants Janssen’s BCMA CAR-T therapy JNJ-4528 Breakthrough Therapy Designation for multiple myeloma indication
Issue 45 - Dec 6, 2019
  • LOWY: Paylines are dropping because NCI is drawing more applicants who would’ve previously gone elsewhere

    After an examination of the causes of an avalanche of grant applications directed at NCI, institute officials found that new applications largely come from principal investigators  who are switching their research focus to cancer. No other  NIH institute or center faces such pressure.

  • NCI Director’s Report

    Sharpless reflects on his time at FDA: “The engine producing new cancer therapies and diagnostics is doing very well”

    The progress in cancer exceeds that of any other therapeutic area right now—at least as far as FDA is concerned, NCI Director Ned Sharpless said at a Dec. 3 joint meeting of the Board of Scientific Advisors and the National Cancer Advisory Board.

  • Senate committee votes 18-5 in support of Hahn, but questions his commitment to aggressive e-cigarette policy

    A Senate committee Dec. 3 cleared the path for Stephen M. Hahn to become the next FDA commissioner, though some Democratic and Republican senators voiced concerns that he wouldn’t take aggressive action to ban flavored e-cigarettes in this role.

  • AACR, Research!America urge Congress to pass spending bill with funding boost for health agencies

    The American Association for Cancer Research and Research!America are urging Congress to pass the FY20 appropriations bill by Dec. 20.

  • In Brief

    • Williams, Ingram, Mitchell to join President’s Cancer Panel
    • Belani named IASLC chief science officer
    • ACCC project focuses on multidisciplinary cutaneous squamous cell carcinoma care
    • Nimer receives Oscar de la Renta Endowed Chair in Cancer Research
    • Barker named chief strategy officer at USC Lawrence J. Ellison Institute for Transformative Medicine
    • Car named Agios chief scientific officer
    • Peterson receives $1.4M grant for innovative approach to attacking metastatic TNBC
    • Mt. Sinai receives $1M grant for prostate cancer research
  • Funding Opportunities

    ACS and Flatiron Health launch real-world data impact award

    The American Cancer Society and Flatiron Health launched a joint grant-making program that supports both organizations’ goals of accelerating cancer research and improving treatment and care options for patients.

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  • Clinical Roundup

    • Study finds wide county-level variation in rates of surgery for early-stage lung cancer
    • Tecentriq + Avastin combination demonstrates improvement in OS, PFS in HCC
    • Alunbrig demonstrates reduced risk of death, disease progression in ALK+ NSCLC
    • Experimental targeted therapy may be better for repeat kidney cancer patients than FDA-approved counterpart, study finds
    • Duke researchers develop technique to visually depict how cancer cells grow and spread in colon tissue
  • Drugs & Targets

    • FDA approves Tecentriq + chemo as initial treatment metastatic non-squamous NSCLC indication
    • FDA approves FoundationOne CDx as a Companion Diagnostic for Piqray in new indication
    • FDA grants Priority Review to Merck’s Supplemental Biologics License Application for Keytruda in NMIBC indication
    • FDA accepts NDA for pemigatinib in previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements
    • China approves Keytruda for first-line treatment in metastatic squamous NSCLC+chemo indication
    • Lynparza approved in China as a first-line maintenance therapy in BRCA-mutated advanced ovarian cancer indication
  • NCI Trials

    NCI Trials for December 2019

    The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month.