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Quick Hits: ASCO Roundup – Speeding Up Cancer Drug Approvals and PPIs May Be Useful in Throat Cancer

 

By Alanna McCatty

June 7, 2018

Quick Hits: Questions Over Accelerated Approval and Availability of Drugs Under Expanded Access

Patients with a tough-to-treat pancreatic cancer lived longer on a 4-drug chemotherapy combination than on the current standard single cancer drug, according to a study. Based on the results, presented during the recent American Society of Clinical Oncology (ASCO) conference, the powerful 4-drug chemotherapy regimen known as folfirinox will likely serve as the new standard of care for patients battling early stage pancreatic cancer, which is primarily treated with surgery. Researchers examined 500 patients from 77 centers in France and Canada for nearly 4 and a half years. Patients either received the 4-drug combo intravenously every two weeks for about 6 months or the single drug Gemzar (gemcitabine) 3 times a month over a 6-month period. The results found that patients taking folfirinox survived a little over 54 months, while patients taking Gemzar only lived 35 months. Overall, the 4-drug combo was associated with a 36% reduction in the risk of death. Posted June 4, 2018. Via CBS News.

Taking a high dose acid-reducing medicine such as Nexium in combination with aspirin may help thwart throat cancer, according to new findings presented at ASCO. In a new study, researchers randomly assigned 2,563 people with Barrett’s esophagus – a precursor to developing esophageal cancer- to 4 treatment groups: the high dose proton pump inhibitor (PPI) Nexium (esomeprazole) with aspirin, a high dose of the PPI without aspirin, a low dose of Nexium with aspirin and a low dose of Nexium without aspirin. After following the patients for nearly 9 years, researchers found that patients taking a high dose of Nexium with a low-dose aspirin for at least 7 years had a moderately reduced risk of developing esophageal cancer. “Based on these data, we believe people with heartburn should talk with their doctor about their risk of Barrett’s esophagus, but they should not self-medicate with these medications,” said lead study author Janusz Jankowski, MD. Posted June 4, 2018. Via Health News Review.

FDA Commissioner Scott Gottlieb has pinpointed new ways to speed up the cancer drug approval process. During ASCO, Gottlieb discussed a new effort to eliminate regulatory barriers that delay the review process for potentially promising cancer therapies. Gottlieb referred to the new review process as a “real-time oncology review” that is already being piloted in applications for expanded use of cancer drugs that are currently approved. If proven successful, the process will be expanded to applications for new cancer therapies. Additionally, the FDA will be trying out a shared application document that will allow agency reviewers to add their comments to background documents submitted by companies. Posted June 2, 2018. Via Reuters.

Alanna McCatty

Alanna McCatty

Alanna McCatty is founder and CEO of McCatty Scholars, an organization that devises and implements financial literacy programs for students to combat the nationwide issue of the loss of educational opportunity due to the ramifications of burdensome student debt. At MedShadow, she reports on new findings and research on the side effects of prescription drugs. She is a graduate of Pace University.

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Last updated: June 7, 2018