20160304 - Mar 4, 2016
ISSUE 9 – MARCH 4, 2016PDF



NCI Developing Mouse Models To Succeed NCI-60 Cell Lines

The NCI-60, a panel of 60 cancer cell lines that have become the Rosetta Stone for the development of anticancer drugs, may be entering its twilight years as NCI develops new, and more expansive, patient-derived xenografts, or PDX models.

For over 25 years, the NCI-60, a set of about a dozen tissue types—leukemia, non-small cell lung, small cell lung, colon, CNS, melanoma, ovarian, renal, and breast—have been used to perform initial screens on over 100,000 compounds.

 

Conversation with The Cancer Letter

Doroshow: Evidence Suggests PDX Models Come Closer to Simulating Human Cancer

NCI is developing patient-derived xenograft mouse models as a potential substitute for the NCI-60 cell lines, a standard screen which experts say can no longer keep up with advances in cancer research and targeted molecular therapy.

“The goal is to try to understand whether these new models will be more successful in providing a better reflection of the underlying biology in the context of the clinical history and treatment history of patients from whence the tissues came,” said James Doroshow, director of the NCI Division of Cancer Treatment and Diagnosis and deputy director for clinical and translational research.

Slamming the Door

Part VI: The Provost’s Choice

After my conversation with Gilman, I called MD Anderson and asked to talk with somebody about the $18 million grant for a biotech incubator.

First, folks at the press shop told me that they view the controversy arising from the application as CPRIT’s problem.

Let’s see: the wife of president of MD Anderson gets a grant seemingly out of turn, causing a political disaster, and this is not an MD Anderson problem?

National Academy of Medicine Publishes Report on Categorizing Different Ovarian Cancers

Ovarian cancer should not be categorized as a single disease, but as many different cancers involving the ovary, according to a report published by the National Academy of Medicine.

Questions remain on how and where various ovarian cancers arise, said the report that also presents research opportunities for reducing the number of women who are diagnosed with or die from ovarian cancers. Roughly two-thirds of women are diagnosed at an advanced stage when the cancer has already spread beyond the ovary, of which less than 30 percent survive past five years. The report was also sponsored by the Centers for Disease Control and Prevention.

Funding Opportunity

FDA Providing $2 Million for Natural History Studies in Rare Diseases

FDA will provide $2 million in two to five research grants for the study of the natural history of rare diseases. The objective of the grants is to expedite the development of products for these conditions.

The Feb. 29 announcement marks the first time FDA will provide funding through its Orphan Products Grants to collect data on the progression of specific rare diseases in individuals over time.

In Brief

  • Joan Massagué wins Pezcoller-AACR International Cancer Research Award

  • David Weiner named executive vice president at The Wistar Institute

  • Douglas Levine named director of gynecologic oncology at NYU Perlmutter Cancer Center
  • Lauren Streicher joins Northwestern Medical Group as medical director

  • Michael Bukosky appointed chief operating officer of USMD Holdings Inc.

  • International Cancer Genome Consortium authorizes 1,000th user

  • IBM and New York Genome Center to collaborate using Watson technology

  • Vantage Oncology LLC acquired by McKesson Specialty Health

 Drugs and Targets

  • Imbruvica granted approval for first-line CLL patients

  • Health Canada approves Opdivo for metastatic NSCLC

  • FDA grants orphan drug designation to SELLAS’s WT1 cancer vaccine

  • EMA grants orphan drug designation to venetoclax

  • FDA and EMA grant orphan designations to FLAG-003 for glioma

  • Merck KGaA, Pfizer and Verastem enter into avelumab research agreement

  • NanoString Technologies and Merck to collaborate on Keytruda assay

 

20160226 - Feb 26, 2016
ISSUE 8 – FEB. 26, 2016PDF



Slamming the Door

Part V: Gilman’s Resignation

Gilman’s letter of resignation, dated May 8, 2012, concludes with a hard slam:

“The purpose of this letter is to indicate my intention to resign from CPRIT, effective (with your permission) on October 12, 2012. At that time I will have worked for CPRIT for over three years—I believe longer than originally anticipated.

“During that time we have launched strong programs because funding decisions have been based on high-level competitions, where the judges have been some of the best cancer researchers and physicians in the country—free of conflicts of interest and all coming from outside of Texas.

“It was exciting to launch this program, to design effective requests for applications, and to oversee the peer review process.



Capitol Hill Briefing Focuses on Moonshot’s Provision to Integrate FDA Cancer Portfolio

When the White House proposed a $1 billion startup fund for the National Cancer Moonshot, a largely unexpected directive to reform FDA raised many questions among oncology insiders.

The agency will create a virtual Oncology Center of Excellence, the administration proposals and budget documents state.

Alas, nobody can claim to understand what “virtual” means in this context, and how the $75 million in proposed fiscal 2017 mandatory funds would be used to “leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices.”

In Brief

  • Laurie Glimcher named president and CEO at Dana-Farber

  • Robert Califf confirmed as FDA Commissioner

  • Mandi Pratt-Chapman named associate center director at GW Cancer Center
  • Steve Limentani named VP and chief research officer at Mission Health

  • Robert Korngold receives lifetime achievement award from the American Society for Blood and Marrow Transplantation

  • Breast Cancer Research Foundation expands research program with Pfizer portfolio

  • Bharat Aggarwal has seven papers retracted from Biochemical Pharmacology 

  • Commission on Cancer honors 27 programs for outstanding achievement

  • Kids V Cancer named one of top 10 most innovative companies

  • Indiana University Simon Cancer Center receives grant from Kay Yow Cancer Fund
Drugs and Targets

  • FDA approves Gazyva for follicular lymphoma

  • FDA approves Afinitor for GI or lung neuroendocrine tumors

  • FDA grants Breakthrough Designation to PKC412 (midostaurin)

20160219 - Feb 19, 2016
ISSUE 7 – FEB. 19, 2016PDF



Should ODAC Vote? Yes? No? Undecided?

At its most recent meeting, in July 2015, the FDA Oncologic Drugs Advisory Committee voted…

No, it didn’t vote!

Breaking with a long-standing tradition, the agency asked ODAC members to “discuss” the key questions of risk vs. benefit of an experimental therapy instead of reducing their answers to a yea-or-nay vote. Agency officials are mum on the subject of whether not voting has become a thing.

News Analysis

Rejected Therapy Reveals Inconsistency of FDA Procedures for Drugs, Immunotherapies

Reform of the FDA oncology program is emerging as the immediately tangible element of the Obama administration’s moonshot program.With a modest $75 million commitment, the administration may be able to standardize the manner in which elements of modern cancer care are reviewed and approved by the regulatory agency (The Cancer Letter, Feb. 12).

As it stands, immunological and cellular cancer therapies as well as diagnostics don’t go through the same review procedures as cancer drugs and biologics.

Slamming the Door

Part IV: Nobel Laureate in Crosshairs

In early 2012, Gilman was under the impression that CPRIT was functioning smoothly.

Then, to his surprise, the first of a series of controversies surfaced.

CPRIT’s peer reviewers had evaluated 40 applications for Multi-Investigator Research Applications, the largest CPRIT grants designed to fund team science, recommending that seven of these project receive funding. This was no small undertaking. The applications described multiple projects and core facilities.

Report: Medicare Pays 340B Hospitals Less Part B Drug Reimbursement

A group advocating for the 340B Drug Discount Program examined the widely held belief that health care organizations enrolled in the controversial federal program receive significantly higher reimbursement for drugs than institutions that do not take part in the program.Previously, a July 2015 study by the Government Accountability Office found that, per beneficiary, Medicare Part B drug spending was indeed higher at 340B hospitals than at non-340B hospitals.

In Brief

  • Arnold Foundation gives $7.2 million to drug pricing programs
  • Joan Schiller named deputy director at Inova Cancer Institute
  • Jeannie Lee receives 2016 Lurie Prize
  • Canadian Cancer Society names four excellence award winnerse
  • Marcia McNutt named president of National Academy of Sciences
  • Medical Oncology & Hematology Associates of Northern Virginia joins Inova Medical Group