There are currently few therapy options for patients with advanced stage pancreatic cancer. Yesterday I received this good news from our friends at the pharmaceutical company, Celgene, via a press release:
CELGENE ANNOUNCES U.S. FDA GRANTS PRIORITY REVIEW FOR ABRAXANE® sNDA IN ADVANCED PANCREATIC CANCER
European Medicines Agency Accepts Regulatory Submission of Type II Variation for ABRAXANE for the Treatment of Advanced Pancreatic Cancer
BOUDRY, Switzerland – (May 23, 2013) – Celgene International Sàrl, a subsidiary of Celgene Corporation (Celgene) (NASDAQ: CELG) today announced that the U.S. Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) for the use of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine for the first–line treatment of patients with advanced pancreatic cancer.
The FDA grants Priority Review to medicines that, if approved, have the potential to offer significant improvement compared to marketed products or provide a treatment where no adequate therapy exists. The goal for completing a Priority Review is six months. The Prescription Drug User Fee Act (PDUFA) date for the sNDA for ABRAXANE is set for September 21, 2013.
In April 2013, the European Medicines Agency (EMA) has also accepted for review a Type II Variation to the current Marketing Authorization Application (MAA) for ABRAXANE, in combination with gemcitabine, for the first–line treatment of patients with advanced pancreatic cancer. Celgene plans to submit dossiers for registration in other countries/regions during 2013.
Both applications included data from an open-label, phase III, randomized, international study, Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT) involving 861 patients with metastatic pancreatic cancer. Results from this study were recently presented at the American Society of Clinical Oncology’s (ASCO) 2013 Gastrointestinal Cancers Symposium in January.
Celgene is preparing a development plan for a phase III, international, multicenter, randomized controlled trial evaluating the activity of ABRAXANE plus gemcitabine in the adjuvant pancreatic cancer setting.
ABRAXANE is not currently approved for the treatment of advanced pancreatic cancer.
As I mentioned at the top of my post, there is little doctors can do for someone with advanced pancreatic cancer. And since symptoms normally don’t appear until it’s too late, the most common outcome is a prognosis of two years or less.
A close friend’s son-in-law is currently battling advanced pancreatic cancer at Mayo Clinic in Rochester, Minnesota. Given only a few months to live at diagnosis, his chemotherapy seems to be helping slow things down.
In cases like this, just a few extra months can mean so much to a patient and their friends and families. I researched Abraxane a bit. It is currently FDA approved for use in breast and lung cancer. As I suspected, it only adds a few short months to the average patient’s life that takes the drug. But some are doing much better than that. So for some patients, the inevitable side effects and extra time spent undergoing medical care might be worth the risk.
Here’s an excerpt from a great site, Medical News Today, that discusses the efficacy of Abraxane when used in pancreatic cancer patients:
Abraxane Improves Survival Among Pancreatic Cancer Patients
Celegene Corp’s drug Abraxane (paclitaxel protein-bound particles for injectable suspension) was found to be effective at improving overall survival among pancreatic cancer patients when combined with chemotherapy, according to results from the drug’s phase III clinical trial.
Even though Pancreatic cancer is a relatively uncommon form of cancer – making up only 2.1% cancer cases – it is one of the leading causes of cancer related deaths killing around 38,000 people in the U.S. every year. It is one of the most difficult forms of cancer to treat, especially as it is usually detected at very late stages.
Treatment is currently quite limited in extending the survival of patients with the cancer. However, recent drug trials have been showing promise, another study indicated that a drug called metformin is able to eliminate cancer stem cells and could work effectively along with chemotherapy. Although pancreatic cancer is relatively uncommon and accounts for only 2.1% of all newly diagnosed cancers, it is the fourth most common cause of cancer death in the United States.
The MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study involved 861 participants and was set up to evaluate the effectiveness of treating pancreatic patients with Abraxane and chemotherapy compared to chemotherapy alone.
Impressive trial results
Results from the study revealed that 35% people on the combination of Abraxane and chemotherapy were alive at the end of the first year compared to only 22% who just underwent chemotherapy. This translates into a 59% increase in one-year survival as well as double the rate of survival in two years for the patients on Abraxane verus those who only received the chemotherapy. Those were solely on chemotherapy survived for only 6.7 months compared to a median of 8.5 months among those who also took Abraxane.
The Executive Vice President, Global Head Hematology & Oncology Clinical Research, Celgene Corporation, Jean-Pierre Bizzari M.D., said:
“We are excited by the results of the Abraxane MPACT study and the potential this treatment combination may bring to patients with advanced pancreatic cancer. As the largest phase III real-world clinical trial in advanced pancreatic cancer, the clinically meaningful findings seen across key study endpoints and patient subgroups are a reflection of our ongoing commitment to develop innovative new therapies in critical areas of need.”
Joseph Nordqvist’s article doesn’t stop there. If you would like to read more, here’s the link:
I, too, suffer from an incurable cancer, multiple myeloma. But I was given years as a prognosis when I was first diagnosed. Enough time to check-off most of the items on my bucket list. My heart was saddened when I learned of my good friend’s son-in-law. 6 months simply isn’t enough time!
Pattie and I wish everyone who is battling pancreatic cancer all our best. Hopefully this new drug is only a sign of things to come, and when combined with other therapies may provide significantly more overall survival benefit. That happens when multiple myeloma drugs are used in combination.
Feel good and keep smiling! Pat