Patient Advocates, Industry, Government, and Private Foundations Collaborate to Accelerate the #Path2Cures

June 18, 2014

UPTON: “Collaborative and innovative efforts like these are in keeping with the 21st Century Cures initiative…”

A new study hopes to accelerate the #Path2Cures for advanced cases of lung cancer. The Associated Press reports, “Its goal is to speed new treatments to market and give seriously ill patients more chances to find something that will help. Instead of being tested for individual genes and trying to qualify for separate clinical trials testing single drugs, patients can enroll in this umbrella study, get full gene testing and have access to many options at once.” FDA cancer drugs chief, Dr. Richard Pazdur, hopes this will “minimize the number of patients exposed to ineffective therapies.”

“It’s encouraging and exciting to see FDA embrace projects like Lung-MAP as we continue to work together to accelerate the discovery, development, and delivery cycle of new cures and treatments,” commented Energy and Commerce Committee Chairman Fred Upton (R-MI). “Collaborative and innovative efforts like these are in keeping with the 21st Century Cures initiative and we look forward to continuing to work together in the coming months and years to bring more cures and treatments to patients more quickly.”

June 17, 2014

New study aims to rapidly test lung cancer drugs

A bold new way to test cancer drugs started Monday in hundreds of hospitals around the U.S. In a medical version of speed dating, doctors will sort through multiple experimental drugs and match patients to the one most likely to succeed based on each person's unique tumor gene profile.

It's a first-of-a-kind experiment that brings together five drug companies, the government, private foundations and advocacy groups. The idea came from the federal Food and Drug Administration, which has agreed to consider approving new medicines based on results from the study.

Its goal is to speed new treatments to market and give seriously ill patients more chances to find something that will help. Instead of being tested for individual genes and trying to qualify for separate clinical trials testing single drugs, patients can enroll in this umbrella study, get full gene testing and have access to many options at once.

The study, called Lung-MAP, is for advanced cases of a common, hard-to-treat form of lung cancer -- squamous cell. Plans for similar studies for breast and colon cancer are in the works.

"For patients, it gives them their best chance for treatment of a deadly disease," because everyone gets some type of therapy, said Ellen Sigal, chairwoman and founder of Friends of Cancer Research, a Washington-based research and advocacy group that helped plan and launch the study. "There's something for everyone, and we'll get answers faster" on whether experimental drugs work, she said.

Cancer medicines increasingly target specific gene mutations that are carried by smaller groups of patients. But researchers sometimes have to screen hundreds of patients to find a few with the right mutation, making drug development inefficient, expensive and slow.

One of the leaders of the Lung-MAP study -- Dr. Roy Herbst, chief of medical oncology at the Yale Cancer Center -- said he once screened 100 patients to find five that might be eligible for a study, and ultimately was able to enroll two….

About 500 hospitals that are part of a large cancer treatment consortium around the country will take part, and some private groups want to join as well, Herbst said.

"Nothing like this has ever been done before," where such comprehensive testing will be done to match patients to experimental drugs, he said. …

Read the full article online HERE

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