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ISSUE 33 – SEPT. 11, 2015PDF

What’s in a Suffix?

FDA’s Dilemma: How to Name Biologics

 

After a courtroom victory against Amgen Inc. this summer, the last of the obstacles was removed for the first biosimilar agent—a white blood cell growth factor—to enter the U.S. market.

Zarxio (filgrastim-sndz), sponsored by Sandoz Pharmaceuticals, a unit of Novartis, appeared on the U.S. market Sept. 3, offering a lower-priced alternative to the branded product, Neupogen.

With biosimilars about to appear on the market, FDA is preparing to reconsider the manner in which these agents—as well as the reference products they copy—are named.

 

HRSA Publishes Long-Awaited 340B Mega-Rule

The Health Resources and Services Administration issued the long-awaited “mega-rule” intended to define who qualifies for deep discounts on drug prices under the federal 340B program.

Established in 1992 to benefit hospitals and clinics that serve low-income and uninsured patients, the 340B Drug Pricing Program has expanded exponentially in recent years.

GAO to Investigate Power Morcellation Harms

The U.S. Government Accountability Office said it would investigate the controversy stemming from wide use of power morcellators, gynecological devices now known to spread undetected cancers during hysterectomies and myomectomies.

The GAO’s Sept. 4 move comes after 12 members of Congress wrote a letter requesting an investigation.

Obituary

Gianni Bonadonna, 81, Pioneering Researcher

Gianni Bonadonna, 81, a pioneering cancer researcher whose work focused on Hodgkin’s lymphoma and breast cancer, died Sept. 7.

His death was announced by the Istituto Nazionale Tumori of Milan.

Bonadonna research included the initial studies on the clinical efficacy of adriamycin (doxorubicin), epirubicin and bleomycin; a number of seminal trials on adjuvant and primary chemotherapy for high-risk breast cancer; as well as a combined modality for the treatment of Hodgkin’s disease—in 1972, he designed a new combination of drugs known as ABVD: adriamycin, bleomycin, vinblastine and dacarbazine.

CVS Marks First Anniversary Of Stopping Tobacco Sales

CVS Health marked the first anniversary of ending tobacco sales at its CVS/pharmacy locations, and released study data showing a reduction in cigarette purchases over the past year.

The company also announced a joint initiative between CVS Health and Scholastic to launch a school-based tobacco-prevention program.

70th Annual Lasker Awards Go To Witkin, Elledge, Allison, Medecins Sans Frontieres

The 70th annual Lasker Awards went to: Evelyn Witkin and Stephen Elledge for basic medical research; James Allison for clinical research; and Medecins Sans Frontieres for public service.

The awards carry an honorarium of $250,000 for each category, and will be presented Sept. 18 in New York City.

In Brief

  • Chad Mirkin wins first Sackler Prize from the National Academy of Sciences

  • Arteaga and Alt awarded scientific prize by the American-Italian Cancer Foundation
  • Herbert Fritsche receives award from International Society of Oncology and Biomarkers

  • Trovagene launches European Trovagene Research Institute
Drugs and Targets

  • FDA grants Priority Review to Alectinib in lung cancer

  • Janssen and Alligator Bioscience enter agreement
  • Sequenom to collaborate with UC San Diego

  • Vaccinogen enters agreement with Dublin City University over DiCAST
  • OICR and Structural Genomics Consortium make drug prototype available to the research community

  • PhRMA publishes report on U.S. drugs in development
20150911 - Sep. 11, 2015
ISSUE 32 – SEPT. 4, 2015PDF

UT Chancellor Mandates Unprecedented Shared Governance Structure at MD Anderson

 

After years of turmoil and plunging morale at MD Anderson Cancer Center, the UT System took what observers describe as an unprecedented step—forming a Shared Governance Committee.

The new structure, instituted Sept. 1, disbands the once powerful Executive Committee, thereby changing the cancer center’s top-down power structure.

The new governance committee is designed to incorporate input from the faculty, and serve as the top advisory body to the institution’s president, Ronald DePinho.

 

Editorial

Judge: Amgen Can’t Depose Cancer Letter Reporter (Me)

A federal judge ruled that Amgen Inc. cannot force me to answer questions related to a 2007 story that sparked a class action suit by investors and triggered a change in FDA regulations of erythropoiesis-stimulating agents.

Judge Amit Mehta, of the U.S. District Court for the District of Columbia, quashed a subpoena filed by Amgen that sought information related to my reporting of a story about a critically important clinical trial showing that patients who received Aranesp did worse than patients who did not.

NCI-MATCH Trial Opens

ECOG-ACRIN opened the NCI-MATCH precision medicine trial, the largest, most scientifically rigorous precision medicine trial in cancer to date.

NCI-MATCH seeks to determine whether matching certain drugs or drug combinations to people whose tumors have specific gene abnormalities will effectively treat their cancer, regardless of their cancer type.

ASCO Updates Policy on Genetics and Genomic Testing

The American Society of Clinical Oncology issued an updated policy statement on genetic and genomic testing for cancer susceptibility.

Published in the Journal of Clinical Oncology, the statement reviews the ways in which new technologies are transforming the assessment and identification of inherited cancer susceptibility, and makes a series of recommendations for the optimal deployment of these technologies in oncology practice.

Obituary

UNMC’s Sidney Mirvish, 86

Cancer researcher Sidney Mirvish died at age 86. His research into nitrosamines and carcinogenesis led to changes in the way lunch meats, hot dogs and sausages were made.

Mirvish served as professor emeritus in the Eppley Institute for Research in Cancer and Allied Diseases at the University of Nebraska Medical Center, where he was faculty member for 46 years. Mirvish died due to complications following emergency surgery on Aug. 18.

In Brief

  • Edith Mitchell named president of National Medical Association

  • Robert DiPaola, Stephen Gruber, and Candace Johnson named to AACI Board of Directors
  • NIH Director Francis Collins awarded Leadership in Personalized Medicine Award

  • Massimo Cristofanilli named associate director for precision medicine at Northwestern University Lurie Cancer Center
  • Jeffrey and W. Kimryn Rathmell appointed to leadership roles at Vanderbilt University Medical Center

  • Lois Travis named director of survivorship research program at Indiana University Simon Cancer Center

  • Rachel Humphrey named chief medical officer of CytomX

  • Donald Sheldon appointed regional president at University Hospitals

  • Keith Perry named chief information officer at St. Jude

  • Northwestern Medicine names breast cancer OncoSET program

  • CPRIT awards seven grants, totaling $23 million

Drugs and Targets

  • FDA approves Varubi for CINV

  • European Commission grants authorization to Unituxin for pediatric neuroblastoma
  • FDA grants Orphan Designation to Toca 511 and Toca FC

  • FDA grants Orphan Designation to MTG-20
  • FDA grants Priority Review to MCNA

20150904 - Sep. 4, 2015
August 2015PDF

 

Leukemia

High-Risk Subset of CLL Patients Shows Benefit in Phase II Trial

A statistically significant percentage of chronic lymphocytic leukemia patients in a phase II clinical trial responded to venetoclax therapy.

The open-label study, sponsored by AbbVie, met its primary endpoint, achieving overall response rates in patients with relapsed/refractory or previously untreated CLL with 17p deletion, according to an independent review analysis.

The study enrolled 157 patients, 107 in the main study cohort evaluating efficacy, and 50 patients in the safety expansion cohort.

The primary efficacy endpoint is overall response rate, and the primary safety endpoints are the number and percentage of patients who experienced treatment-related adverse events, changes in physical exam findings, including vital signs, changes in clinical laboratory test results and changes in cardiac assessment findings.

 

Lung Cancer

Atezolizumab Immunotherapy Meets Response Endpoint in Phase II NSCLC Study

A phase II study of atezolizumab immunotherapy met its primary endpoint, shrinking tumors in patients with locally advanced or metastatic non-small cell lung cancer whose disease expressed PD-L1.

The study showed the amount of PD-L1 expressed by a person’s cancer correlated with their response to the medicine.

The study, BIRCH, is an open-label, multicenter, single-arm study that evaluated the safety and efficacy of atezolizumab in 667 people. Results from the study will be presented at an upcoming medical meeting, according to the drug’s sponsor, Genentech, a member of the Roche Group.

Also:

 

Drugs and Targets

European Commission Approves Unituxin in Pediatric High-Risk Neuroblastoma

The European Commission granted a marketing authorization for Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation.

Unituxin is administered in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2, and isotretinoin.

The European approval was based on demonstration of improved event-free survival and overall survival in a multicenter, open-label, randomized trial (ANBL0032) sponsored by NCI under a Cooperative Research and Development Agreement with the drug’s sponsor, United Therapeutics Corp., and conducted by the Children’s Oncology Group.

 

Liver Cancer

ThermoDox plus RFA Increase OS By 58 Percent in HEAT Study

 

Carcinoid Syndrome

Oral Telotristat Etiprate Trial Meets Phase III Primary Endpoint

 

NCI CTEP-Approved Trials for the Month of August

20150831 - Aug. 31, 2015