Monthly Archives: October 2015

FDA approves new treatment for advanced #PancreaticCancer

The U.S. Food and Drug Administration today approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.

According to the National Cancer Institute, there will be 48,960 new cases of pancreatic cancer diagnosed in the U.S. in 2015, and nearly the same number of deaths caused by the disease (40,560). Pancreatic cancer can be difficult to diagnose early and treatment options are limited, especially when the disease has spread to other parts of the body (metastatic disease) and surgery to remove the tumor is not possible.

“Many FDA staff who review drug applications are clinicians as well, so it’s especially rewarding when we are able to expedite access to new treatments for patients with unmet needs,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “By using the Priority Review designation for the application for Onivyde, patients will have earlier access to a drug that helps extend survival.”

The FDA granted Priority Review and orphan drug designations for Onivyde. Priority review status is granted to applications for drugs that, if approved, would be a significant improvement in safety or effectiveness in the treatment of a serious condition. Orphan drug designation provides incentives such as tax credits, user fee waivers, and eligibility for orphan drug exclusivity to assist and encourage the development of drugs for rare diseases.

The effectiveness of Onivyde was demonstrated in a three-arm, randomized, open label study of 417 patients with metastatic pancreatic adenocarcinoma whose cancer had grown after receiving the chemotherapeutic drug gemcitabine or a gemcitabine-based therapy. The study was designed to determine whether patients receiving Onivyde plus fluorouracil/leucovorin or Onivyde alone lived longer than those receiving fluorouracil/leucovorin. Patients treated with Onivyde plus fluorouracil/leucovorin lived an average of 6.1 months, compared to 4.2 months for those treated with only fluorouracil/leucovorin. There was no survival improvement for those who received only Onivyde compared to those who received fluorouracil/leucovorin.

The safety of Onivyde was evaluated in 398 patients who received either Onivyde with fluorouracil/leucovorin, Onivyde alone or fluorouracil/leucovorin. The most common side effects of treatment with Onivyde included diarrhea, fatigue, vomiting, nausea, decreased appetite, inflammation in the mouth (stomatitis) and fever (pyrexia). Onivyde was also found to result in low counts of infection-fighting cells (lymphopenia and neutropenia). Death due to sepsis following neutropenia has been reported in patients treated with Onivyde.

The labeling for Onivyde includes a boxed warning to alert health care professionals about the risks of severe neutropenia and diarrhea. Onivyde is not approved for use as a single agent for the treatment of patients with metastatic pancreatic cancer.

Onivyde is marketed by Merrimack Pharmaceuticals Inc. of Cambridge, Massachusetts.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

click here to be taken to this article

*credit verbatim via  http://www.fda.gov *

FDA Approves Post-Gemcitabine Therapy

FDA APPROVES POST-GEMCITABINE THERAPY FOR PATIENTS WITH METASTATIC PANCREATIC CANCER

Today, The U.S. Food and Drug Administration (FDA) approved a novel therapy for patients with metastatic pancreatic adenocarcinoma – the most common form of pancreatic cancer – whose disease has progressed following gemcitabine-based therapy, offering new hope against a disease that will claim the lives of more than 40,000 individuals this year.

“This is a pivotal achievement for the pancreatic cancer community because it provides a new treatment option for some patients facing this difficult disease,” said Julie Fleshman, president and CEO of the Pancreatic Cancer Action Network. “We applaud the dedication of those involved in this advancement, knowing it will impact our goal to double pancreatic cancer survival by 2020.”

ONIVYDE™ (irinotecan liposome injection), in combination with fluorouracil (5-FU) and leucovorin, is the first-ever therapy approved by the FDA for the treatment of patients with metastatic adenocarcinoma of the pancreas whose disease has progressed following gemcitabine-based therapy.

The FDA’s approval of ONIVYDE in combination with 5-FU and leucovorin is based on results from an international phase III clinical study, further illustrating clinical trials as the mechanism that enables improvements in patient outcomes.

According to Merrimack Pharmaceuticals, the maker of ONIVYDE, the therapy was found to improve median overall survival from 4.2 to 6.1 months when compared to the control group of patients who received 5-FU and leucovorin alone.

At present, the five-year survival rate is a mere seven percent. To combat these statistics, the Pancreatic Cancer Action Network set a bold and aggressive goal to double pancreatic cancer survival by 2020.

“This ambitious goal is only possible with positive results from clinical trials and the approval of new therapies like this one. We encourage all patients with pancreatic cancer to consider clinical trials when looking at their treatment options,” added Fleshman.

To find a pancreatic cancer clinical trial, call the Pancreatic Cancer Action Network at 877-272-6226 or visit https://clinicaltrials.pancan.org/.

Follow the Pancreatic Cancer Action Network on Twitter, Instagram or on Facebook.

About the Pancreatic Cancer Action Network
The Pancreatic Cancer Action Network is the national organization creating hope in a comprehensive way through research, patient support, community outreach and advocacy for a cure. The organization is leading the way to increase survival for people diagnosed with this devastating disease through a bold initiative — The Vision of Progress: Double Pancreatic Cancer Survival by 2020. To continue to accelerate progress, a goal to raise $200 million by 2020 is also in place. Together, we can Wage Hope and rewrite the future of pancreatic cancer.

(click here to continue reading this article)

*credit verbatim via pancan.org*

Bombing survivor focuses on finding cure for #PanCan

A local man who survived the Boston Marathon bombing hopes to make a change and help find a cure for people with pancreatic cancer.

In 2012, avid runner Phil Kent, 59, trained for the Boston Marathon, but four months before the race he had chronic back pain that resulted in a devastating diagnosis – pancreatic cancer.

“I was in total shock and disbelief for the most part because every other aspect of my life was healthy and I felt good,” he said.

Phil, while thinking his days were numbered, focused on making his dream of running the prestigious race into a reality. His physician, Dr. Gary Schwartz at Kaiser Permanente Woodland Hills, believed exercise would give Phil the fuel he needed to beat his disease.

“When you talk to him about marathons his eyes light up. That’s a very important part of his being,” Schwartz said.

Doctors tailored Phil’s chemotherapy for training and his surgery was scheduled for 10 days after the big race.

But then tragedy struck. As he neared the finish line in Boston on April 15, 2013, his wife Sharon stopped him to take a photo. Phil said that ended up saving his life because seconds later the first bomb went off.

In a photo taken overhead, Phil and his two companions can be seen right next to where the second bomb exploded, about 20 yards away from the finish line.

“As we were coming up, we were grabbing our hands to get our picture taken crossing the finish line. That’s the stage we were at and that’s where we were,” he said.

With major pancreatic surgery just days away, Phil believed he would never race again. But he found inspiration in the Hirshberg Foundation, a nonprofit focusing on pancreatic cancer research. His new focus was on the L.A. Cancer Challenge, a race for the cure.

Now, nearly three years after his diagnosis, Phil wants to inspire other pancreatic cancer patients not to give up. In 2014, he got his chance to cross the Boston finish line.

This Sunday, he hopes thousands of supporters will help him complete what he believes is the race to save lives.

To learn more about the 2015 L.A. Cancer Challenge, check out their website at http://support.pancreatic.org/site/.

(click here to continue reading this article)

*credit verbatim via Denise Dador and http://abc7.com/society/local-marathon-runner-focuses-on-finding-cure-for-pancreatic-cancer/1045331/*

Spicy Condiment Fights #PanCAN w/ Accuracy

wasabi-ft1

If you love to eat sushi, and particularly the green mustard with a kick which comes with most Japanese dishes – wasabi – then you could very well be fighting one of the most deadly types of pancreatic cancers around.

Otherwise known as Japanese horseradish, wasabi has been shown to kill human pancreatic cancer cells with accuracy. Specifically, the active compounds of wasabi:

“. . .showed that compounds 6-MITC and I7557, but not I7447, inhibited viability of both PANC-1 and BxPC-3 cells. Morphological observation showed mitotic arrest and apoptosis in 6-MITC- and I7557-treated cells. These two compounds induced G2/M phase arrest and hypoploid population. Percentages of ALDH-positive PANC-1 cells were markedly reduced by 6-MITC and I7557 treatment. The expression of CSC signaling molecule SOX2, but not NOTCH1, ABCG2, Sonic hedgehog, or OCT4, was inhibited by 6-MITC and I7557. In conclusion, wasabi compounds 6-MITC and I7557 may possess activity against the growth and CSC phenotypes of human pancreatic cancer cells.”

In other words, when you eat wasabi, you are protecting your body and prohibiting the creation of pancreatic cancer cells from forming.

(click here to continue reading this article)

*Credit verbatim via Christina Sarich and http://naturalsociety.com*

*image from wired.com*