publication date: Jul. 10, 2015
20150710 - Jul. 10, 2015
ISSUE 27 – JULY 10, 2015PDF

Lilly Drug to Change Squamous NSCLC,

But ODAC’s Opinion is Nuanced


The FDA Oncologic Drugs Advisory Committee July 9 appears to have recommended approval for the Eli Lilly and Co. agent necitumumab.

Yes, the word “appears” has indeed appeared in the previous sentence.

It had to because, in breaking with a long-standing tradition, the agency asked ODAC members to “discuss” the key questions of risk vs. benefit of the experimental therapy instead of reducing their answers to a yea or nay vote.

No vote was taken, but The Cancer Letter’s analysis of ODAC’s discussion suggests that, had a vote been taken, necitumumab would have received an overwhelming 11:1 vote in favor of approval.


Do-It-Yourself Guide to ODAC

Circle One: Yes, No, Maybe

FDA has often asked ODAC members to discuss broad scientific questions. However, the approval questions have, without an exception, been shoehorned into the up-or-down dichotomy.

What is ODAC without a vote on approval questions?

Here, The Cancer Letter has combined a transcript of the ODAC discussion with a coding scale that may provide a clue about how the vote on necitumumab would have gone.

    Huntsman, UNM Cancer Center, and UT Southwestern Receive NCI Comprehensive Designations

    Three cancer centers have been awarded comprehensive status from NCI, the highest designation possible: the Huntsman Cancer Institute at the University of Utah, UT Southwestern’s Harold C. Simmons Cancer Center, and the University of New Mexico Cancer Center.

    A fourth, the Dan L. Duncan Cancer Center at Baylor College of Medicine, is also expected to receive the comprehensive designation, sources said. This will bring the total number of comprehensive centers to 45.

    House Passes 21st Century Cures Act

    The U.S. House of Representatives July 10 passed H.R. 6, The 21st Century Cures Act without amendments by a 344 to 77 vote.

    The bill—designed to modernize clinical trials and streamline the drug approval process—would boost NIH funding by $1.75 billion in mandatory funding a year over the next five years, for a total of $8.75 billion, and FDA’s budget by a total of $550 million.

      ORIEN Partners with Three Cancer Research Centers

      The Oncology Research Information Exchange Network July 9 announced the addition of three cancer institutions to its precision cancer research partnership, bring the total number of partners to nine.

      The new members are the Rutgers Cancer Institute of New Jersey, the University of Southern California Norris Comprehensive Cancer Center, and Morehouse School of Medicine.

        In Brief

        • Carolyn Britten named director of Hematology/Oncology at the Medical University of South Carolina

        • Marcia McNutt nominated to be president of the National Academy of Sciences

        • Kevin Fitzpatrick named CEO of CancerLinQ LLC

        • Memorial Sloan Kettering Cancer Center to open new lung cancer research center

        • American College of Radiology launches Commission on Patient Experience

        • The Association of Community Cancer Centers launches the Institute for Clinical Immuno-Oncology

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