Healthcare Industry News:  NSCLC 

Biopharmaceuticals Oncology Regulatory

 News Release - March 18, 2015

Hong Kong Authority Approves Abraxane(R) as First-Line Treatment For Late-Stage Pancreatic Cancer

HONG KONG, March 18, 2015 -- (Healthcare Sales & Marketing Network) -- Celgene announced today that a new treatment option for late-stage pancreatic cancer is now available for use in Hong Kong. Approved by the Department of Health, Abraxane® (paclitaxel formulated as albumin-bound nanoparticles) is indicated for use in combination with gemcitabine, another chemotherapy drug, as first-line treatment for patients with late-stage (metastatic) pancreatic cancer. The approval provides hope for extending the lives of patients with metastatic pancreatic cancer and represents the first approved treatment for this aggressive disease in nearly eight years.

Abraxane® is an albumin-bound form of paclitaxel that is manufactured using patented nab® technology or nanotechnology. It disrupts the internal support structure of tumor cells, which is believed to interfere with their growth. Abraxane® in combination with gemcitabine has been shown to improve survival in patients with metastatic pancreatic cancer.[1]

Pancreatic cancer is one of the deadliest cancers globally and in Hong Kong

Pancreatic cancer is the seventh-leading cause of cancer-related death world-wide with 338,000 new cases diagnosed in 2012.[2] According to the Hong Kong Hospital Authority, pancreatic cancer is the number six cancer killer in Hong Kong with over 500 deaths every year.[3]

"The early stages of this cancer do not usually produce symptoms, so the disease is generally advanced when it is diagnosed," said Dr. Kevin Loh, a medical oncologist from OnCare Cancer Center, Hong Kong.

"The disease is one of the deadliest cancers and treatment options are limited. Even with aggressive treatment, the prognosis of pancreatic cancer is poor - around 74% of patients die within the first year of diagnosis, and less than 6% will survive more than five years. In Hong Kong, the number of new cases reported annually is similar to the number of deaths, indicating poor survival rates," commented Dr. Loh.

In fact, the pancreas is the only major cancer site for which no improvements in mortality rates is predicated for either males or females.[4] These data highlight the urgent need for new treatment advances in metastatic pancreatic cancer.

A new treatment option to help improve overall survival rate of patients with pancreatic cancer

The Department of Health's approval of Abraxane® was based on the results of an open-label, randomized, international phase III clinical trial, one of the largest ever conducted in metastatic pancreatic cancer. The study included 861 participants and compared treatment with Abraxane® plus gemcitabine with gemcitabine alone. Participants treated with Abraxane® plus gemcitabine demonstrated a statistically significant improvement in overall survival with a 28% reduction in risk of death (8.7 vs 6.6 months; hazard ratio=0.72; P[1,5]

Importantly, this is the first study to report long-term survivorship in a disease with very poor prognosis. Compared with patients treated with gemcitabine alone, patients treated with Abraxane® plus gemcitabine had a 59% (35% vs 22%) and 125% (10% vs 5%) increase in overall survival after 1 and 2 years of treatment, respectively.[5] This improved survival was sustained even after 3 years of treatment with Abraxane® plus gemcitabine. Grade 3 and higher side effects of neutropenia, fatigue, and peripheral neuropathy were reported more frequently in patients treated with Abraxane® plus gemcitabine versus gemcitabine alone.[1]

"The approval of Abraxane® for late-stage pancreatic cancer in Hong Kong is a big step toward bringing the first new treatment option in many years to people diagnosed with this deadly disease," said Thomas Karalis, General Manager of East Asia, Celgene.

"We are beginning the important work of helping physicians and patients gain access to Abraxane® plus gemcitabine, which has shown statistically significant and clinically meaningful improvements in overall survival compared to gemcitabine alone. Celgene remains committed to developing innovative treatments to improve the lives of patients dealing with this devastating cancer disease," he added.

About Pancreatic Cancer

Pancreatic cancer is the seventh-leading cause of cancer-related death world-wide and number six cancer killer in Hong Kong. The disease is not usually diagnosed until it is at an advanced stage. For this reason, most patients have a poor prognosis, with more than one-half of patients diagnosed after their cancer has spread to other organs (click the link to view the disease infographic and learn more about pancreatic cancer: Pancreatic cancer infographic).

About Abraxane®

Abraxane® is an albumin-bound form of paclitaxel that is manufactured using patented nab® technology. Abraxane® is formulated with albumin, a human protein, and is free of solvents.

Abraxane® was first approved in January 2005 by the U.S. Food and Drug Administration (FDA) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Abraxane® is now approved in more than 50 countries for the treatment of metastatic breast cancer.

In October 2012, Abraxane® was approved by the FDA for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. Abraxane® is also approved for the treatment of NSCLC in Argentina, Australia, Chile, Ecuador, Guatemala, Europe, Hong Kong, Japan, New Zealand and Singapore.

In September 2013, the FDA approved Abraxane® as first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. Abraxane® is also approved for the treatment of metastatic pancreatic cancer in more than 40 countries.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com.

For product and media related enquiries, please contact:

Edelman Public Relations Worldwide (Hong Kong)
Anna Wong
Tel: +852-2837-4769
Email: anna.wong@edelman.com

Celgene Limited (Hong Kong)
Jasmine Hoo
Tel: +65-6572-5124
Email: jhoo@celgene.com

References:

1.Von Hoff DD, et al. N Engl J Med. 2013;369(18):1691-1703.

2.World Cancer Research Fund International. Pancreatic cancer statistics. Available at:http://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/pancreatic-cancer-statistics

3.Hong Kong Hospital Authority. Pancreatic Cancer. Available at:http://www21.ha.org.hk/smartpatient/en/cancerin_focus/details.html?id=109

4.Malvezzi M, et al. Ann Oncol. 2013;24(3):792-800.

5.Goldstein D, et al. J Natl Cancer Inst. 2015;107(2):dju413.


Source: Celgene

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Please address inquiries directly to the issuing company.



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