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ISSUE 18 – May 6, 2016PDF

art 42-18 fda on the moon final

Virtual is Not Enough

FDA’s Critics Call for Full Integration of Oncology Center Under Biden’s Moonshot

The White House moonshot to accelerate progress in cancer research directs FDA to consolidate its oncology portfolio.

However, oncology insiders say the manner in which the presidential initiative will be implemented could make the difference between political balderdash and genuine improvement in FDA regulation of cancer therapies.

The entire controversy boils down to the interpretation of one word: Virtual.

Moonshot Director Addresses AAADV Workshop

Greg Simon, executive director of the cancer moonshot task force, addressed the FDA-sponsored workshop for Accelerating Anticancer Agent Development and Validation in North Bethesda, Md., May 4.

He discussed the goals for the moonshot initiative, how the program could fit into the next presidential administration, and how to take the project international.

Slamming the Door

Part XI: Gilman’s Teachable Moment

During our first conversation in the spring of 2012, Gilman said that he would go public unless he received assurances that CPRIT would retain its integrity after his departure.

He wanted guarantees that the structure he built would not be turned into a political pigsty. With guarantees being hard to come by, it was obvious that he would end up slamming the door hard. Publicly.

FDA to Regulate All Tobacco Products, Including E-Cigs, In Historic Expansion

FDA issued final regulations for all tobacco products, including electronic cigarettes, cigars and hookah. The rules, with provisions aimed at restricting youth access and requiring premarket clearance for new products, will take effect Aug. 8.

The federal regulations include: not allowing tobacco products to be sold to persons under the age of 18, both in person and online; requiring age verification by photo ID; not allowing the selling of covered tobacco products in vending machines, unless in an adult-only facility; and not allowing the distribution of free samples.

National Academy of Sciences Elects 105 Members

The National Academy of Sciences elected 84 new members and 21 foreign associates from 14 countries in recognition of their distinguished and continuing achievements in original research.

Those elected today bring the total number of active members to 2,291 and the total number of foreign associates to 465. Foreign associates are nonvoting members of the academy.

Funding Opportunity

CureSearch Taking Applications
For Pediatric Research Awards

CureSearch for Children’s Cancer is taking applications for its International Grand Challenge Awards addressing three challenges in pediatric cancer treatment. The awards will be worth between $2 million and $3 million.

In Brief
  • American Cancer Society and CVS Health launch three-year antismoking campaign
  • Pershing Square Sohn Research Alliance funds seven young investigators

  • Sean Parker recognized by the Vatican for philanthropic work

  • Richard O’Reilly receives inaugural Society of Memorial Sloan Kettering Prize

  • David Weiner receives professorship and grant from W.W. Smith Charitable Trust

  • Canadian Cancer Clinical Trials Network launches national awareness campaign

Drugs and Targets
  • Eribulin receives EU approval in liposarcoma

  • Health Canada approves Lynparza in ovarian cancer

  • CHMP issues positive opinions for Imbruvica and Afinitor

  • AstraZeneca and Foundation Medicine to collaborate on diagnostic assays

  • AbbVie and CytomX Therapeutics to collaborate on probody drug conjugates

 

20160506 - May. 6, 2016
April 2016PDF

 

Head and Neck Cancers

Opdivo Extends OS in Phase III Squamous Cell Carcinoma Trial

A phase III trial of PD-1 inhibitor Opdivo showed significant survival benefit at one year—compared to investigator’s choice of methotrexate, docetaxel or cetuximab—in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Patients treated with Opdivo (nivolumab) experienced a 30 percent reduction in the risk of death, with a median overall survival of 7.5 months (95% CI: 5.5-9.1) compared to 5.1 months (95% CI: 4.0-6.0) for investigator’s choice (HR=0.70 [97.73% CI: 0.51-0.96] p=0.0101).

The one-year survival rate for Opdivo was 36 percent compared to 16.6 percent for investigator’s choice. The safety profile of Opdivo in CheckMate-141 was consistent with prior studies, with no new safety signals identified.

     

    Melanoma

    Opdivo-Yervoy Combination Demonstrates Two-Year Survival Rate of 69 Percent

    Overall survival data from CheckMate-069, a phase II trial of a Opdivo and Yervoy combination regimen in patients with previously untreated advanced melanoma, demonstrated a two-year overall survival rate of 69 percent compared to 53 percent for Yervoy alone (HR=0.58 [95% CI: 0.31-1.08]) in patients with BRAF wild-type advanced melanoma.

    CheckMate-069 evaluated 142 patients with previously untreated unresectable or metastatic melanoma who received either the Opdivo and Yervoy combination regimen (n=95) or Yervoy alone (n=47). The trial included patients with BRAF wild-type and BRAF V600 mutation-positive melanoma, and randomization was stratified by BRAF mutation status.

       

      Drugs and Targets

      FDA Grants Accelerated Approval To Venclexta Tablets in CLL

      FDA granted accelerated approval to Venclexta tablets (venetoclax) for patients diagnosed with chronic lymphocytic leukemia with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.

      The indication was approved based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

      Also:

         

        Ovarian Cancer

         

        Prostate Cancer

        Study: SBRT Delivers 98.6% Cure Rate at Five-Year Followup

         

        Soft Tissue Sarcoma

        Researchers: Radiation After Surgery Benefits Older Patients More than Younger Patients

         

        NCI CTEP-Approved Trials for the Month of April

         

        Letter to the Editor

        GOG Foundation Sends Rebuttal Letter to Oncolytics Biotech

        20160502 - May. 2, 2016
        ISSUE 17 – April 29, 2016PDF



        Guest Editorial

        The Moonshot: A View from Europe

        By Peter Boyle

        “And I believe we need a moonshot in this country to cure cancer.”

        With these words, Vice-President Joe Biden gave the first public hint of a new specific, major program to be launched and funded by the U.S. government.

        President Barack Obama reiterated this development in his State of the Union address announcing a new national effort to get it done and placing Vice President Biden as leader of this initiative.

        The appointment of Vice President Biden to head the initiative is an inspired choice.

        Of course, let’s not forget that in 1971 President Richard Nixon launched a not dissimilar initiative and yet 45 years later, there still remains an on-going war against this feared group of diseases, despite progress in many aspects. Times change, knowledge advances, and there are many signs that this new initiative holds out a better chance of success.

         

        NCI’s New Genomic Platform Seeks to Enable Data Sharing for Biden’s Moonshot

        NCI is preparing to open the Genomic Data Commons, a $20 million big data endeavor aimed at making raw genomic data publicly available.

        The GDC, NCI’s largest bioinformatics effort since the ill-fated caBIG, will go live June 1. The database will be interoperable and publicly available to qualified researchers. Anyone will be able to submit data for consideration.

        While work on the GDC began over two years ago, the initiative is being launched at a time when leading oncology groups are positioning themselves to play a central role in the White House’s moonshot initiative.

        Conversation with The Cancer Letter

        NCI’s Staudt and Kibbe: Data Commons Will Publish Annotated Raw Genomic Data

        The Genomic Data Commons, NCI’s latest big data project, is poised to become a major player in oncology bioinformatics when it opens June 1.

        The GDC aims to become oncology’s go-to database for comprehensive, raw genomics information. NCI officials said this sets the GDC apart from other bioinformatics projects, which are vying to play a role in the White House moonshot initiative.

        “When the other groups are sharing the data, what they are doing is sharing very derived data that is divorced from the actual data,” said Louis Staudt, director of NCI’s Center for Cancer Genomics. “The GDC is doing something different.”

        Capitol Hill

        Senate Committee Looks to Fund Medical Innovation Legislation

        Over 150 organizations sent an open letter to the leaders of the Senate Health, Labor, Educations and Pensions Committee, supporting them for advancing legislation that will form the basis of the Senate’s version of the 21st Century Cures Act, which passed the House last year.

        The Senate committee has passed 19 bills since February—collectively referred to as medical innovations legislation—which include agreements on NIH funding, support for the Precision Medicine Initiative, and changes to FDA and NIH hiring power. Now, the committee has to work to find ways to pay for the programs before sending the bills to the full Senate.

        PCORI Approves $44.4 Million for 21 Research Studies

        The Patient-Centered Outcomes Research Institute approved $44.4 million in funding for 21 new patient-centered comparative clinical effectiveness research studies.

        Several studies will focus on cancer, including comparing ways to improve colorectal cancer screening, develop a more patient-centered approach to assessing the quality of care for people with cancer, and assessing the effectiveness of different treatment strategies for ductal carcinoma in situ among older women.

        In Brief
        • Jennifer Pietenpol named executive vice president for research at Vanderbilt

        • Margaret Foti named an honorary member of the Oncology Nursing Society

        • John Weston named chief operating officer of the Prostate Cancer Foundation

        • Al Benson III elected president of National Patient Advocate Foundation executive board

        • Avinash Desai named vice president at Eisai Inc. 

        • MD Anderson Cancer Center names eight Sabin Family Fellows

        • NCCN publishes patient education materials for NHL

        • Kids v Cancer launches Compassionate Use Navigator tools

        • Albert Einstein College of Medicine enters agreement with Jiangsu Hengrui Medicine

        • Wistar Institute and Cormorant Pharmaceuticals form drug partnership

        • MD Anderson and Summit Medical Group launch partnership in New Jersey

        • Geisinger Health System sets higher accrual goals for DNA sequencing study

        • AbbVie acquires Stemcentrx and Rova-T drug candidate

        • AbbVie forms collaboration with argenx in immuno-oncology

        • Indiana University raises $1.2 million for research at tailgate gala

        Drugs and Targets
        • FDA grants approval to Cabometyx tablets in renal cell carcinoma

        • FDA grants Orphan Drug Designation to DelMar’s VAL-083 

         

        20160429 - Apr. 29, 2016