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Panel Laments Lack of Options for Advanced Breast Ca

November 17, 2014

By Medpage Today, Charles Bankhead

The lack of options for advanced breast cancer has created a sense of urgency for high-quality research and clinical trials to address a multitude of unanswered questions, a guideline panel concluded.

Though treatment advances have extended the duration of survival, advanced breast cancer remains almost uniformly fatal. Consequently, the principal goals have been to improve the length and quality of life for patients.

Non-publication of large randomized clinical trials: cross sectional analysis

November 1, 2014

By The BMJ (British Medical Journal), Christopher W. Jones, MD

Introduction

Randomized clinical trials are a critical means of advancing medical knowledge. Clinical trials depend on the willingness of participants to expose themselves to the risks of randomization, blinding, and unproven interventions. The ethical justification for these risks is that society will eventually benefit from the knowledge gained from the trial.1 Because the risks involved in trial participation may be significant, and because individual trial participants often do not benefit directly from trial participation, substantial safeguards have been implemented to protect the interests of study participants both prior to and during the trial.2 These safeguards take multiple forms, including oversight by institutional review boards, the informed consent process, and data and safety monitoring boards. Until recently, the protection of the interests of study participants after trial completion has received significantly less emphasis. This began to change in 1997 with the signing of the Food and Drug Administration Modernization Act in the United States, which mandated that the US Department of Health and Human Services establish a registry of clinical trials, thereby providing permanent, public access to information on the conduct of both publicly and privately funded clinical trials.3

Pfizer's palbociclib on track for early 2015 launch

October 15, 2014

By PM Live

Pfizer will get a rapid review at the US FDA for its new breast cancer candidate palbociclib, meaning it could be approved in the first quarter of 2015.

The FDA has said it will deliver a verdict on palbociclib - one of the most anticipated drugs in Pfizer's pipeline with peak sales potential of $3bn-$4bn according to analysts - by April 13 next year.

Pfizer is seeking approval of palbociclib in combination with Novartis' Femara (letrozole) as a first-line treatment for postmenopausal women with oestrogen receptor positive (ER+), HER2-negative advanced breast cancer who have not received previous systemic treatment.

Metastatic Breast Cancer Alliance landmark report finds MBC research underfunded and identifies opportunities to close gaps for

October 15, 2014

By Press Release

NEW YORK, Oct. 14, 2014 /PRNewswire/ -- On National Metastatic Breast Cancer (MBC) Awareness Day, October 13, the MBC Alliance revealed the results of their Landscape Report, Changing the Landscape for People Living with Metastatic Breast Cancer. The MBC Alliance, representing 29 cancer organizations, releases the report on its one-year anniversary after a comprehensive year-long analysis of current MBC research and patient needs, as well as information and services.

Roche Breast Cancer Drug Perjeta Appears to Greatly Extend Patients’ Lives

September 28, 2014

By Andrew Pollack, NY Times

A drug used to treat advanced breast cancer has had what appears to be unprecedented success in prolonging lives in a clinical trial, researchers reported on Sunday.

Patients who received the drug — Perjeta, from the Swiss drug maker Roche — had a median survival time nearly 16 months longer than those in the control group.

NIH exceptional responders to cancer therapy study launched

September 24, 2014

By Fierce Medical Devices

The Exceptional Responders Initiative, a study to investigate the molecular factors of tumors associated with exceptional treatment responses of cancer patients to drug therapies, was launched today by the National Cancer Institute (NCI), part of the National Institutes of Health. Scientists will attempt to identify the molecular features of tumors that predict whether or not a particular drug or class of drugs will be beneficial. Investigators will examine tumor specimens from patients in clinical trials who achieved an exceptional response relative to other trial participants, or other patients who achieved an exceptional and unexpected response to a non-investigational therapy.

Despite IPO plans, Syndax raises another $5 million for epigenetic breast cancer treatment

September 23, 2014

A company in the burgeoning field of epigenetics has raised about $5 million in debt financing, right on the heels of refiling for an initial public offering.

The company’s developing an epigenetic therapy for treatment-resistant cancers called entinostat. It was granted breakthrough therapy designation by the Food and Drug Administration, thanks to data from Phase IIB trials in metastatic breast cancer. It began Phase III trials in June, which are expected to be complete by mid-2017.

Despite IPO plans, Syndax raises another $5 million for epigenetic breast cancer treatment

September 22, 2014

By MedCity News, Meghana Keshavan |

A company in the burgeoning field of epigenetics has raised about $5 million in debt financing, right on the heels of refiling for an initial public offering.

The company’s developing an epigenetic therapy for treatment-resistant cancers called entinostat. It was granted breakthrough therapy designation by the Food and Drug Administration, thanks to data from Phase IIB trials in metastatic breast cancer. It began Phase III trials in June, which are expected to be complete by mid-2017

Tripathy Offers Perspective on HER2-Positive Breast Cancer

August 14, 2014

By Onc Live: Christina Izzo

The ever-evolving treatment landscape for patients with HER2-positive breast cancer leaves several questions unanswered regarding therapeutic sequences and whether an optimal standard of care exists. To provide further perspective on current paradigms, OncLive interviewed Debu Tripathy, MD, a breast cancer expert whose clinical research efforts focus on novel therapeutics, resistance, and the discovery of biomarkers.

Tripathy, a professor of medicine and the co-leader of the Women's Cancer Program at the University of Southern California Norris Comprehensive Cancer Center, serves as the primary investigator for the Systematic Therapies for HER2-positive Metastatic Brest Cancer Study (SystHERs), which hopes to provide information on treatment patterns across the United States.

Merrimack Pharmaceuticals Announces Initiation of HERMIONE, a Randomized Trial of MM-302 in Patients With Advanced HER2-Positive

August 12, 2014

By Merrimack Pharmaceuticals press release

Trial is Recruiting Patients Previously Treated With Ado-Trastuzumab Emtansine (T-DM1) and Pertuzumab

CAMBRIDGE, Mass., Aug. 11, 2014 (GLOBE NEWSWIRE) -- Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK) today announced the initiation of a global, open-label, randomized Phase 2 trial of MM-302, a HER2-targeted nanoliposomal encapsulation of doxorubicin, in combination with trastuzumab (Herceptin®) in patients with HER2-positive locally advanced or metastatic breast cancer. The trial was designed with input from the U.S. Food and Drug Administration (FDA) to support a potential accelerated approval application.

"While there have been new therapies approved in the HER2-positive setting, there is no standard of care for patients whose cancer progresses despite treatment with trastuzumab, T-DM1 and pertuzumab. In our experience to date, MM-302 has shown promising clinical activity and an acceptable safety profile in patients with metastatic breast cancer who have progressed on HER2-directed therapies. We are moving this trial forward with a goal of transforming the standard of care for this population," said Thomas Wickham, Ph.D., Vice President of Development and MM-302 Project Team Leader.

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