Tag Archives: fda

Discrepancies in access to new cancer drugs revealed

Researchers say the results demonstrate the need for better collaboration between doctors and health authorities on an international scale, to ensure patients have access to the best treatments. Coordinated action is needed at an international level to ensure new cancer-fighting drugs are approved in a timely manner, oncologists said at the Congress. Their call came after a survey revealed that patients in some regions sometimes wait years longer than their counterparts elsewhere for new drugs to be approved. The drug approval process is important to ensure that safe and effective therapies are made available for patients, explains study senior author Dr Sunil Verma from Sunnybrook Odette Cancer Center, Toronto, Canada. …

Study finds known lung cancer oncogenes also drive colorectal cancer

"When you have known oncogenes that are already targeted by FDA-approved drugs, it just made sense to look for these oncogenes in other cancers," says Marileila Varella Garcia, PhD, investigator at the CU Cancer Center and professor at the CU School of Medicine. "By rethinking the way we understand cancers — as their genetic mutations and not just as the sites where they live in the body — we see that a therapy that targets a specific mutation may show benefit in treating any other cancer that shares the same mutation," says Dara Aisner, MD, PhD, investigator at the CU Cancer Center and molecular pathologist at the CU School of Medicine…

Approaches to pain assessment in cancer clinical trials

A new paper published by Cancer External Site describes approaches to pain measurement used in oncology clinical trials submitted to the U.S. Food and Drug Administration that are consistent with current FDA guidance principles. The purpose of the paper is to assist drug developers to include meaningful pain endpoints when designing cancer trials. "Measurement of pain and other symptoms is an essential part of cancer trials…

Triple-negative breast cancer target for drug development identified

UCSF researcher Luika Timmerman, PhD, an investigator in the UCSF Helen Diller Family Comprehensive Cancer Center, found that many cell lines obtained from triple-negative breast cancer are especially dependent on cystine, one of the 20 amino acids that are the building blocks of proteins that all cells need. Timmerman used an FDA-approved drug to inhibit activity of a transporter protein that ferries cystine into triple-negative breast cancer cells, and found that it significantly inhibited their growth in culture and when the cancer cells were transplanted into mice…