Expanded Options Available for Metastatic Pancreatic Cancer Treatment

by U.S. Medicine

November 6, 2013

SUMMIT, NJ — The approved uses of Abraxane — paclitaxel protein-bound particles for injectable suspension, albumin-bound — have been expanded by the Food and Drug Administration to treat patients with metastatic pancreatic cancer in late stages.

“Patients with pancreatic cancer are often diagnosed after the cancer has advanced and cannot be surgically removed,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “In these situations, and in situations when the cancer has progressed following surgery, options like Abraxane can help prolong a patient’s life.”

Abraxane is intended to be used in conjunction with gemcitabine in patients with metastatic pancreatic cancer. Its expanded usage was considered under the FDA’s priority review program, which provides for an expedited review of drugs. Abraxane also was granted orphan product designation for pancreatic cancer because of its use in rare diseases or conditions.

A clinical trial with 861 participants who were randomly assigned to receive Abraxane plus gemcitabine or gemcitabine alone was used to establish Abraxane’s safety and effectiveness for pancreatic cancer treatment. Participants treated with the combination of the two drugs lived an average 1.8 months longer than those treated with gemcitabine alone, while also experiencing a delay in progression-free survival that was, on average, 1.8 months later than the participants receiving the single therapy.

Pyrexia, dehydration, pneumonia and vomiting were the most common serious side effects reported, with other clinically important serious side effects including sepsis and pneumonitis. Common side effects observed in Abraxane plus gemcitabine-treated participants include neutropenia, thrombocytopenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea and rash.

Abraxane previously was approved to treat breast cancer in 2005 and non-small cell lung cancer in 2012. It is marketed by Celgene, based in Summit, NJ, while gemcitabine is marketed by Indianapolis-based Eli Lilly.

Comments are closed here.

Related Articles

Better Survival for NSCLC Patients Treated by Military Medicine

Does universal healthcare access provided by the MHS translate into improved patient outcomes for non-small cell lung cancer?

PhARMD Program Continues to Expand Pharmacists’ Clinical Role in VA

A tool developed by the VA has raised the profile of pharmacists as critical members of patient care teams at the VA, leading to a doubling of the number of pharmacists serving as providers.

U.S. Medicine Recommends

More From pharmacy


PhARMD Program Continues to Expand Pharmacists' Clinical Role in VA

A tool developed by the VA has raised the profile of pharmacists as critical members of patient care teams at the VA, leading to a doubling of the number of pharmacists serving as providers.


Is It Time to Abandon One-Size-Fits-All Dosing for Antibiotics?

Increased obesity among veterans and the general population might be leading to more hospitalizations for infections and greater instance of failed treatment in patients who have been hospitalized.


VA Evaluates Form to Improve Function in Medication Labels

When time is of the essence, good design saves lives. That was the lesson of a recent experiment in Pittsburgh that tested whether anesthetist trainees would grab the right medication in a stressful simulated operating room scenario or make a potentially fatal mistake.


Better Retention and Outcomes With One Tablet Therapy for HIV Patients

Patients taking a single tablet to control HIV had better viral suppression and stayed in care at higher rates than patients who took multiple pills.


Demand surges for popular army clinical pharmacy course

With pharmacists from across the DoD and VA clamoring for spots in the Clinical Pharmacy Course at Army Medical Department Center and School (AMEDDCS) in Fort Sam Houston, TX, organizers offered back-to-back programs this spring, with another scheduled for August.

Subscribe to U.S. Medicine Print Magazine

U.S. Medicine is mailed free each month to physicians, pharmacists, nurse practitioners, physician assistants and administrators working for Veterans Affairs, Department of Defense and U.S. Public Health Service.

Subscribe Now

Receive Our Email Newsletter

Stay informed about federal medical news, clinical updates and reports on government topics for the federal healthcare professional.

Sign Up