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ISSUE 6 – FEB. 12, 2016PDF



Obama’s $4.1 Trillion Budget Proposes Mandatory Funds for $1 Billion Moonshot

President Barack Obama Feb. 8 unveiled his budget proposal for the 2017 fiscal year—a $4.1 trillion spending blueprint that is unlikely to be passed by a Republican-controlled Congress.

The administration’s proposal appears to cut the NIH existing budget by $1 billion in discretionary funding and makes up the difference with mandatory funding.

In a joint snub, the House and Senate budget committees declined to hold a hearing for Shaun Donovan, the director of the Office of Management and Budget. The move marks the first time in 41 years that Congress has refused to review a president’s budget.

Conversation with The Cancer Letter

Sigal: FDA Should Consolidate Cancer Portfolio

President Barack Obama’s Feb. 8 budget request for fiscal year 2017 slates $75 million in additional funding for FDA for the creation of a virtual Oncology Center of Excellence.

The proposal is arguably the most tangible component of Vice President Joe Biden’s National Cancer Moonshot program, which aims to double progress in cancer research and drug development over the next five years.

Slamming the Door – How Al Gilman Taught Texas a Lesson in Science

Part III: 18,000 Bosses

Between the fall of 2011 and the spring of 2012, I watched MD Anderson from afar, and I didn’t think about CPRIT at all.

Friends who attended early meetings with Ronald DePinho soon after he became MD Anderson’s president said that he was literally grading presentations made to him by faculty members and administrators.

“This was a C-,” he would say.

It was difficult to get a B.

In Brief

  • Miami Cancer Institute joins MSK Cancer Alliance
  • Ramalingam named deputy director of Winship Cancer Institute
  • David McConkey appointed director of Johns Hopkins Bladder Institute
  • Sylvester Comprehensive Cancer Center creates two endowed chairs
  • Pat Keel appointed CFO of St. Jude
  • Paul Vanveldhuisen named COO of The Emmes Corporation
  • American Urological Association, Urology Care Foundation and Chesapeake Urology Associates form partnership
  • Bonnie J. Addario Foundation launches second phase of crowdsourcing challenge
  • ESPN’s Jimmy V Week for Cancer Research raises $3.2 million
Drugs and Targets

  • FDA grants orphan designation to tazemetostat
  • PDS Biotechnology signs CRADA with NCI
  • FDA grants orphan designation to antifungal drug candidate CD101 IV

 

20160212 - Feb. 12, 2016
ISSUE 5 – FEB. 5, 2016PDF



Slamming the Door

Part II: Cancer’s Butt

CPRIT’s review process appeared to have become a major annoyance to those who wanted to redraft the criteria for dispensing the princely sum of $300 million a year. Texas geography and Texas politics did matter—a lot.

The cross-state competition between MD Anderson Cancer Center and UT Southwestern Medical Center proved to be especially important.

MD Anderson has long been a clinical powerhouse, the kind of place you go with a complicated cancer. If it ramped up its basic science, the cancer center would be better positioned to understand the origins of cancer and make more fundamental contributions to treatment of cancers, including discovering useful drug candidates and moving them from the bench to the clinic.

White House Promises $1 Billion for Cancer MoonshotThe White House announced a $1 billion initiative Feb. 1 to jumpstart the national cancer moonshot program—an ambitious proposal first announced by President Barack Obama during his final State of the Union address.

Vice President Joe Biden, whose son Beau died of brain cancer in May 2015 at age 46, is leading the program, which aims to achieve a decade’s worth of progress within the next five years.

FDA Releases New Opioid Plan as Senators Stall Robert Califf’s Confirmation as Commissioner

Robert Califf, the nominee to serve as the next FDA commissioner, and other FDA leaders called for a broad plan to reassess the agency’s approach to prescription opioid medications. The move comes as Senators block a vote on his confirmation for the top post.

Sen. Edward Markey (D-Mass.) and Democratic presidential candidate Sen. Bernie Sanders of Vermont have both placed procedural holds on Califf’s confirmation, citing the agency’s policies and methods for approving opioids, as well as Califf’s financial ties to the pharmaceutical industry.

In Brief

  • Lonial named head of hematology and oncology at Winship Cancer Institute
  • Stand Up To Cancer Canada announces brain cancer dream team
  • Keith Hanson McGregor named CEO of ESMO
  • M. Beatriz Currier joins Miami Cancer Institute
  • H. Benjamin Harvey and Courtney Moreno receive ACR fellowship
  • Van Andel Research Institute-SU2C Dream Team trial enters phase II
Drugs and Targets

  • Venetoclax receives third FDA breakthrough designation
  • FDA tells Telesta they need another phase III MCNA trial
  • Mayo Clinic collaborates with Morphotek in triple-negative breast cancer study.
20160205 - Feb. 5, 2016
January 2016PDF

 

Melanoma

Phase III Trial Binimetinib Increases PFS in NRAS-Mutant Melanoma vs. Dacarbazine

Array BioPharma reported top-line results from the ongoing phase III clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma, demonstrating that the study met its primary endpoint of improving progression-free survival when compared with dacarbazine treatment.

The median PFS on the binimetinib arm was 2.8 months versus 1.5 months on the dacarbazine arm (HR=0.62, 95% CI 0.47-0.80, p < 0.001). Binimetinib was generally well-tolerated and the adverse events reported were consistent with previous results in NRAS melanoma patients. Binimetinib is a small molecule MEK inhibitor which targets key enzymes in the RAS/RAF/MEK/ERK pathway.

Breast Cancer

Survey of Breast Cancer Cell Function Identifies New Drug Uses, Combinations

Researchers conducted a large analysis of breast cancer cell function, saying the results suggest dozens of new uses for existing drugs, new drug discovery targets, and new drug combinations.

“This study represents the largest survey yet of how the genetic changes in breast cancer cells interfere with pathways critical to their growth and survival, pathways that might be targeted by combinations of new or existing drugs,” said lead study author Benjamin Neel, director of the Perlmutter Cancer Center at NYU Langone Medical Center.

The study results were published in the journal Cell. The researchers combined genetic analyses of more breast cancer cell types than studied previously, new statistical methods, and comparisons with databases of molecular signatures and the effects of anti-cancer drugs.

Ovarian Cancer

Trial of 200,000 Women Shows Screening Can Reduce Mortality by 20 Percent

One of the largest randomized trials ever has concluded that ovarian cancer screening may reduce ovarian cancer mortality by an estimated 20 percent after follow up of up to 14 years, but researchers say longer follow-up is needed to determine the ultimate mortality reduction and if screening the general population is cost effective.

The United Kingdom Collaborative Trial of Ovarian Cancer Screening enrolled 202,638 women, aged 50-74 years, between 2001 and 2005 through 13 trial centers in England, Northern Ireland and Wales. The study results were published in The Lancet.

The study tested the hypothesis that screening for ovarian cancer in the general population can reduce disease mortality without significant harm, in line with screening programs for other cancers.

Colorectal Cancer

Cervical Cancer

Analysis Evaluates Moore Criteria for Bevacizumab Effectiveness

NCI CTEP-Approved Trials for the Month of January
Drugs and Targets

  • Opdivo-Yervoy combination granted accelerated approval in metastatic melanoma
  • Halaven approved for unresectable or metastatic liposarcoma
  • Zepatier approved for chronic hepatitis C
  • Health Canada grants conditional approval to Blincyto in Ph- acute lymphoblastic leukemia
  • FDA grants breakthrough designations to BI1482694 (HM61713) and venetoclax
  • Priority review granted to lenvatinib in renal cell carcinoma
20160201 - Feb. 1, 2016