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First approved solvent-free taxane chemotherapy to demonstrate nearly double response rate compared to solvent-based paclitaxel
Abraxis Bioscience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, has now made ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) (nab-paclitaxel) available in China for the treatment of patients with metastatic breast cancer. In a global Phase III clinical trial, and in a Phase II clinical trial in China, the tumor response rate for patients who received ABRAXANE for the treatment of metastatic breast cancer was nearly double the response rate compared to patients who received solvent-based paclitaxel.i
In China, women with breast cancer are often diagnosed in advanced stages of the disease.ii Breast cancer is the leading cause of death among patients with malignant tumors in China. iii According to the Beijing Municipal Health Bureau, which compared data from 1998, the occurrence rate of breast cancer among Beijing's women residents has increased approximately 110 percent in the past decade.iv
"We are seeing a significant rise in the incidence of breast cancer in China due to the aging population and the environmental factors," said Prof. Zefei JIANG, Director of Breast Cancer Dept., Beijing No. 307 Hospital. "The availability of new therapies, like ABRAXANE, is important to meeting the unmet needs of women fighting breast cancer in China."
ABRAXANE is approved by the State Food and Drug Administration for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. The recommended regimen is 260 mg/m2 administered intravenously over 30 minutes every three weeks. ABRAXANE uses a novel technology called nab®-Technology to deliver the drug paclitaxel to the tumor site. The formulation combines paclitaxel with albumin, a naturally occurring protein, which eliminates the need for solvents in the standard delivery of chemotherapy.
"ABRAXANE is a novel chemotherapy. The unique characteristics of the nab-technology platform enable more drug to be delivered directly to tumors by leveraging cancer biology. ABRAXANE is an effective and convenient treatment option for Chinese patients with metastatic breast cancer," said Prof. Binghe XU, Deputy Director of Medical Oncology Dept., Cancer Hospital and Institute, Chinese Academy of Medical Sciences.
In the randomized study comparing nab-paclitaxel with solvent-based paclitaxel in Chinese patients with metastatic breast cancer, ABRAXANE demonstrated a significantly higher overall response rate than solvent-based paclitaxel, consistent with the results seen in the global Phase III study in Caucasian patients. The primary endpoint was investigator assessed overall response rate and assessment of safety and tolerability. Secondary endpoints included time to tumor progression (TTP), survival and pharmacokinetics. ABRAXANE significantly improved the investigator assessed overall response rate versus solvent-based paclitaxel (54% vs. 29%; P =0.001). In an unplanned analysis, the response rate was greater in the nab-paclitaxel treatment arm for first-line therapy when patients had no prior anthracycline-containing therapy (61% v.21 %, p=0.001).The median time to progression was longer for ABRAXANE than for solvent-based paclitaxel, but the difference was not significant (7.6 months vs.6.2 months p=0.078) . ABRAXANE also achieved a 26 percent improvement in progression free survival when compared to solvent-based paclitaxel (7.6 months vs. 6.2 months; P = 0.118).
Both therapies had acceptable toxicity profiles with the most common toxicities similar between treatment arms. A total of 212 patients were randomized from 29 June 2005 through 1 August 2006. 85 patients (40%) had received prior chemotherapy for metastatic disease. The median age was 50 years, 94 percent of participants were less than 65 years old and 70 percent of participants were postmenopausal.v
The incidences of most adverse events in both treatment arms were generally similar in Chinese patients. Both treatment arms were well tolerated. The incidence of laboratory assessed neutropenia was higher in patients receiving ABRAXANE (92% vs. 77%, p<0.001), although the incidence of grade 3 or 4 neutropenia was not significantly higher (44% vs. 35%, p=0.258). Alopecia was the most common adverse event for ABRAXANE and solvent-based paclitaxel, and was not different between treatment groups (76% vs 81%, p=0.403). No significant difference was seen between the groups in sensory neuropathy (Abraxane 76% vs. solvent-based paclitaxel 74%, P = 0.752).
"Trials conducted with metastatic breast cancer patients in our country have shown the improved efficacy of ABRAXANE compared to solvent-based paclitaxel," said Prof. Zhongzhen Guan, Director of National Clinical Study Center and Chairman of National Anticancer Drug Evaluation Committee. "This randomized study in China confirmed the efficacy and tolerability of ABRAXANE in Chinese patients, resulting in the approval of ABRAXANE in China. Patients treated with ABRAXANE are able to tolerate increased doses of chemotherapy treatment, administered over a shorter time, and with comparable tolerability to solvent-based paclitaxel. Because the product is solvent-free, infusion times are shorter, as little as 30 minutes versus three hours with solvent-based paclitaxel, and premedication is not required to reduce the risk of potentially serious solvent-related hypersensitivity reactions in patients."
"With the launch of ABRAXANE, Chinese women living with advanced breast cancer now have an important new treatment option. We look forward to working with Chinese healthcare professionals to bring ABRAXANE to patients in need," said Mr. Jonathan Zhu, General Manager of Abraxis BioScience China and a native Chinese concludes. "With a presence in the United States, Europe, India and Asia-Pacific, this launch in China reflects our position as an emerging global oncology leader. This is a position we hold with great responsibility and passion as we continue to grow our portfolio and pipeline to provide treatments to patients who need them the most in China."
"The clinical trial results obtained in the Chinese patients are consistent with those from the Caucasian patients, further proved the novel clinical advantages of ABRAXANE in the treatment of breast cancer," said Zhiwen Yao, M.D., Chief Representative and CMO of Abraxis BioScience Beijing Representative Office. "In China, the most populated country in the world, the launch of ABRAXANE will provide a new and attractive option for cancer patients and a great opportunity to maximize the advancement of ABRAXANE in oncology."
ABRAXANE and nab are U.S. registered trademarks of Abraxis BioScience.
i Guan et al. Presented at ASCO 2007, Chicago, Illinois, USA
ii Xinhua New Agency, May 12, 2007
iii Xinhua New Agency, September 17, 2009
iv Beijing Evening News, May 7, 2009
v Guan et al. Presented at ASCO 2007, Chicago, Illinois, USA
About Abraxis Bioscience, Inc.
Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. The company's portfolio includes the world's first and only protein-bound nanoparticle chemotherapeutic compound (ABRAXANE), which is based on the company's proprietary tumor targeting technology known as the nab platform. The first FDA approved product to use this nab platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer and is now approved in 36 countries. The company continues to expand the nab platform through a robust clinical program and deep product pipeline. Abraxis trades on the NASDAQ Global Market under the symbol ABII.
ABRAXANE is a solvent-free chemotherapy treatment option for metastatic breast cancer which was developed using Abraxis BioScience's proprietary nab technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin, a naturally-occurring human protein. By wrapping the albumin around the active drug, ABRAXANE can be administered to patients at higher doses, delivering higher concentrations of paclitaxel to the tumor site than solvent-based paclitaxel. ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: expanded applications for metastatic breast, non-small cell lung, malignant melanoma, pancreatic, gastric and head and neck.
The U.S. Food and Drug Administration approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. For the full United States prescribing information for ABRAXANE please visit www.abraxane.com.
IMPORTANT SAFETY INFORMATION (FROM THE US PRESCRIBING INFORMATION)
The use of ABRAXANE has not been studied in patients with hepatic or renal dysfunction. In the randomized controlled trial, patients were excluded for baseline serum bilirubin >1.5 mg/dL or baseline serum creatinine >2 mg/dL.
ABRAXANE can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with ABRAXANE.
Men should be advised to not father a child while receiving treatment with ABRAXANE.
It is recommended that nursing be discontinued when receiving ABRAXANE therapy.
ABRAXANE contains albumin (human), a derivative of human blood.
Caution should be exercised when administering ABRAXANE concomitantly with known substrates or inhibitors of CYP2C8 and CYP3A4.
ABRAXANE therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 cells/mm3. It is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE. Patients should not be retreated with subsequent cycles of ABRAXANE until neutrophils recover to a level >1,500 cells/mm3 and platelets recover to a level >100,000 cells/mm3.
In the case of severe neutropenia (<500 cells/mm3 for 7 days or more) during a course of ABRAXANE therapy, a dose reduction for subsequent courses is recommended. Sensory neuropathy occurs frequently with ABRAXANE.
If grade 3 sensory neuropathy develops, treatment should be withheld until resolution to grade 1 or 2 followed by a dose reduction for all subsequent courses of ABRAXANE.
Severe cardiovascular events possibly related to single-agent ABRAXANE occurred in approximately 3% of patients in the randomized trial. These events included chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary embolism, and hypertension.
In the randomized metastatic breast cancer study, the most important adverse events included alopecia (90%), neutropenia (all cases 80%; severe 9%), sensory neuropathy (any symptoms 71%; severe 10%), asthenia (any 47%; severe 8%), myalgia/arthralgia (any 44%; severe 8%), anemia (all 33%; severe 1%), infections (24%), nausea (any 30%; severe 3%), vomiting (any 18%; severe 4%), diarrhea (any 27%; severe <1%), and mucositis (any 7%; severe <1%).
Other adverse reactions have included ocular/visual disturbances (any 13%; severe 1%), fluid retention (any 10%; severe 0%), hepatic dysfunction (elevations in bilirubin 7%, alkaline phosphatase 36%, AST [SGOT] 39%), renal dysfunction (any 11%; severe 1%), thrombocytopenia (any 2%; severe <1%), hypersensitivity reactions (any 4%; severe 0%), cardiovascular reactions (severe 3%), and injection site reactions (<1%). During postmarketing surveillance, rare occurrences of severe hypersensitivity reactions have been reported with ABRAXANE.
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