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ISSUE 45 – DEC. 5, 2014PDF

Urgent FDA Action Turns Power Morcellation Into Rarely Used Gynecological Procedure

The power morcellator should no longer be used for hysterectomies or fibroid removal in the vast majority of women getting these procedures, FDA declared in a highly anticipated guidance document Nov. 24.

Using a new authority that bypasses public comment, the agency stopped short of imposing an outright ban on the device, but severely restricted its use.

Top NCI Officials Pledge No Further Consolidation of Clinical Trials System

Top NCI officials made an unusual assurance that the reorganization of clinical trials cooperative groups isn’t a “prelude to reducing the commitment of the NCI to clinical trials-based research.”

The document, published as a letter to the editor of the Journal of Clinical Oncology on Dec. 1, follows up on a meeting Sept. 23, where group chairs and directors of statistical centers asked NCI to assure them that no new cuts are in the works.

Brigham & Women’s Suspends Controversial Morcellation Study As Apparent “Difference of Opinion” with FDA Comes to Light

The Brigham & Women’s Hospital has halted a controversial study that combined power morcellators with “containment bags” intended to capture tissue during minimally invasive gynecological surgery.

Launched earlier this summer, the study was designed to enroll 400 women to test dye leakage in several commercially available bags that have not been cleared by FDA for use with power morcellators.

Varmus’s 2016 Bypass Budget Seeks “Modest” Increase of $823 Million

NCI has published the bypass budget for the fiscal year 2016, asking for $5.754 billion, an $823 million increase over the estimated budget of $4.931 billion.

NYC Doctor Pays $2.35 Million To Settle False Claims Act Suit Over Radiosurgery Reimbursements

A New York City radiation oncologist who specializes in fractionated stereotactic radiosurgery and stereotactic body radiation therapy agreed to pay $2.35 million to resolve a 10-year-old Medicare fraud lawsuit.

 

Drugs and Targets

  • Blincyto granted accelerated approval in R/R ALL
  • Broad Institute, Harvard University, MIT and Editas Medicine form collaboration
  • FDA grants clearance to IQQA-BodyImaging
  • CMS issues final payment decision for Cologuard screening test
photoIn Brief

  • David Chambers named deputy director for implementation science at NCI DCCPS

  • Linda Weiss announces intention to retire from NCI Office of Cancer Centers

  • 2014 John Scott Award winners announced

  • Nicholas Petrelli receives clinical research award from the Association of Community Cancer Centers

  • Anjen Chenn named VP of clinical operations at Metamark

20141205 - Dec. 5, 2014
November 2014PDF

 Melanoma

PD-1 Checkpoint Inhibitor Opdivo First to Demonstrate Survival Benefit in Phase III


A study comparing Opdivo to dacarbazine chemotherapy in treatment naïve advanced melanoma patients marks first PD-1 immune checkpoint inhibitor to demonstrate a survival benefit in a phase III trial.

The trial, CheckMate-066, met its primary endpoint of overall survival, with median OS not reached in the Opdivo (nivolumab) arm, compared to 10.8 months in patients receiving dacarbazine chemotherapy.

The one-year survival rate was 73 percent for Opdivo vs. 42 percent for DTIC, and there was a 58 percent decrease in the risk of death for patients treated with Opdivo (HR: 0.42, p<0.0001).

Also:

 Ovarian Cancer

Phase III Trebananib Trial Fails OS Endpoint In Recurrent Platinum-Resistant Ovarian Cancer

Top-line secondary endpoint results from the phase III TRINOVA-1 trial in women with recurrent platinum-resistant ovarian cancer did not demonstrate a statistically significant improvement in overall survival. The study evaluated trebananib plus paclitaxel versus placebo plus paclitaxel.

Median overall survival was 19.3 months in the trebananib arm versus 18.3 months in the control arm. The data will be submitted to a future medical conference and for publication according to Amgen, trebananib’s sponsor.

In the previously reported primary endpoint analysis, the data demonstrated a statistically significant difference in progression-free survival for trebananib. In that analysis, patients treated with trebananib showed a 34 percent reduction in the risk of disease progression or death (HR = 0.66, 95 percent CI, 0.57, 0.77, p<0.001). The median progression-free survival was 7.2 months in the trebananib arm versus 5.4 months in the control arm.

 Glioblastoma

Phase III Tumor Treating Fields Trial Halted Following Positive Results in Interim Analysis

A phase III trial of Tumor Treating Fields was terminated early following early success detailed in an interim analysis. The trial evaluated patients with newly diagnosed glioblastoma being treated with the NovoTTF-100A System, developed by Novocure, in combination with standard-of-care temozolomide.

The treatment extended both progression-free survival and overall survival compared to temozolomide alone. The trial’s independent data monitoring committee recommended terminating the trial early and allowing all control patients to cross over to the treatment arm.

 Non-Small Cell Lung Cancer

 Prostate Cancer
Galeterone Shows Potential In CRPC AR Variants, Study Says
 NCI CTEP-Approved Trials for the Month of November
 FDA News

  • Cyramza approved in advanced gastric cancer

  • Lymphoseek indication expanded to include mapping in solid tumors

  • Fast Track designation granted to MM-398 adenocarcinoma of the pancreas

  • Orphan Drug designation granted to JCAR015 in ALL

  • FDA taking public comment on “first generic” ANDA processes

20141201 - Dec. 1, 2014
ISSUE 44 – NOV. 21, 2014PDF

As FDA Weighs its Options on Morcellation, Debate Erupts Over Harvard Device Study

Here is what we know: A surgical device used to perform about 100,000 hysterectomies and myomectomies every year in the U.S. has been shown to spread cells from undetected or missed uterine cancers—rapidly upstaging the disease.

And here is what we don’t know: What will FDA do about it?

The agency is under pressure to respond to the growing outcry from patient advocates, who want a ban on the device.

Conversation with The Cancer Letter

Demetri: Morcellation Worsens Outcomes In Patients with Undiagnosed Cancers

As an oncologist who treats sarcoma, George Demetri has seen the adverse consequences of power morcellation, the surgical technique widely used to perform laparoscopic hysterectomies and remove putative fibroids.

In a small minority of cases, these fibroids instead represent unsuspected malignancies—including rare and aggressive leiomyosarcomas—which were impossible to detect prior to the morcellation procedure.

The Cancer Letter is taking a Thanksgiving Break.

The next issue will be published on Dec. 5.

CPRIT Awards 32 Grants

The Cancer Prevention and Research Institute of Texas awarded 20 grants through its product development program, five grants through its prevention program, and seven recruitment grants through its research program, totaling more than $65 million.

ASCO Proposes Principles For Future Debate on Medicaid

The American Society of Clinical Oncology has proposed a set of principles for shaping future debate of the role of Medicaid.

Obituary

Connie Curran, 67, C-Change Executive Director

Connie Curran, 67, the first executive director of C-Change, died Nov. 10.

C-Change brings together leaders in cancer from the public, private, and not-for-profit sectors. 

Curran was born in Berlin, Wis. She held degrees from the University of Wisconsin, DePaul University, and Northern Illinois University. She also is a graduate of Harvard University Business School’s Owner/President Management program.

FDA News

photoIn Brief

  • D. Gary Gilliland Named President and Director of Fred Hutchinson Cancer Research Center

  • Mark Gilbert named chief of Neuro-Oncology Branch at NIH

  • Bert Vogelstein awarded Warren Triennial Prize by Massachusetts General Hospital

  • Susan Mayne appointed director of FDA Center for Food Safety and Applied Nutrition

  • Merck KGaA and Pfizer Inc. to co-develop anti-PD-LI antibody

  • NYU Langone Medical Center and Lutheran Medical Center to create integrated healthcare network

  • Dana-Farber Cancer Institute and Astellas Pharma Inc. announce three-year collaboration

  • Tapimmune Inc. and Vaccine & Gene Therapy Institute of Florida form partnership

  • St. Jude Children’s Research Hospital opens Marlo Thomas Center

  • Karmanos Cancer Institute honored by Michigan Cancer Consortium

20141121 - Nov. 21, 2014