BMS Announces NMPA Approval of Abraxane® (nab-paclitaxel) in Combination with Gemcitabine as First-Line Treatment for Metastatic Pancreatic Cancer in China

ShanghaiJanuary 5, 2024PR Newswire -- Bristol-Myers Squibb announced the original tumor treatment drugAbraxane^®(Albumin-bound Paclitaxel for Injection, abbreviated as "Albumin Paclitaxel", Kaysu)^®) has been approved by the China National Medical Products Administration (NMPA) for use in combination with gemcitabine as a first-line treatment for metastatic pancreatic cancer.AbraxaneIt is the original albumin paclitaxel product, and also the only albumin paclitaxel product that has been proven by Phase III clinical studies to significantly improve the survival of patients with pancreatic cancer.

"Pancreatic cancer is one of the most malignant tumors. Statistics from the World Health Organization show that, in 2020, the number of annual deaths in China was approximately 121,900 cases."^[1], ranking among the top of all cancers, is known as the 'king of cancers'. Due to its insidious symptoms, a large number of patients are diagnosed at an advanced stage or even with distant metastasis, making surgery impossible and resulting in a very limited survival period."Professor Lin Shen, Director of the Department of Gastrointestinal Medical Oncology at Peking University Cancer Hospital"Currently, nab-paclitaxel is the first-line standard treatment drug for metastatic pancreatic cancer recommended by major global authoritative guidelines. It not only has clear efficacy and safety profiles but also does not require premedication, making it relatively convenient. Additionally, the survival benefits of its original product have been confirmed by large-scale Phase III randomized controlled trials and validated in a Chinese bridging Phase II study. We believe that the approval of the original nab-paclitaxel will effectively support the standardized clinical diagnosis and treatment of pancreatic cancer in China."

AbraxaneThe approval in China was based on the results of multiple clinical studies. A global large-scale randomized controlled Phase III study, MPACT^[2]A total of 861 patients with metastatic pancreatic cancer who had not previously received chemotherapy were enrolled and randomly assigned to receiveAbraxaneCombined with gemcitabine or gemcitabine alone; the study results showed,AbraxaneThe combination regimen significantly extended the median overall survival (OS) of patients to 8.5 months (6.7 months in the control group, HR 0.72, P<0.001), reducing the risk of death by 28%; moreover,AbraxaneThe objective response rate (ORR) of the combination regimen was more than three times that of the control group (23% vs. 7%), and the median progression-free survival (PFS) showed a significant improvement to nearly 1.5 times that of the control group (5.5 months vs. 3.7 months, HR 0.69, P<0.001). Another multicenter Phase II clinical study conducted in China, PANC-001^[3]The results showed that the recipientsAbraxaneThe ORR for first-line treatment of metastatic pancreatic cancer in Chinese patients treated with gemcitabine combination therapy can reach 35%. In the two studies mentioned above,AbraxaneThe overall tolerability of the combination regimen was good, and the safety profile was generally consistent with the known safety profiles of nab-paclitaxel and gemcitabine. No new safety signals were observed.

Based onAbraxaneThe efficacy demonstrated by the regimen in Phase III clinical trials has led to the recommendation of the nab-paclitaxel plus gemcitabine regimen in major global authoritative treatment guidelines for pancreatic cancer, including the Chinese Society of Clinical Oncology (CSCO) Pancreatic Cancer Diagnosis and Treatment Guidelines.^[4]Listed as a first-line treatment recommendation (Class 1A evidence) for metastatic pancreatic cancer; National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Pancreatic Cancer.^[5]It has also been listed as the preferred option (Category 1 recommendation) for first-line treatment of advanced or metastatic pancreatic cancer.

"As a cornerstone drug for cancer treatment that has been fully validated worldwide, this timeAbraxane"We are delighted that the pancreatic cancer indication has been approved in China. Guided by Bristol-Myers Squibb's 'China 2030 Strategy,' we have consistently focused on the urgent medical needs of Chinese patients, committed to delivering high-quality, original products to meet the unmet needs of patients with serious diseases."Ms. Chen Siyuan, Vice President of Bristol-Myers Squibb, General Manager of China and Asian Regional Markets, and President of Bristol-Myers Squibb China, stated, "We will closely collaborate with all parties to accelerateAbraxane"The availability in China will enable patients with urgent clinical needs to benefit as soon as possible. In the future, we will continue to leverage our innovative leadership in the field of oncology, constantly exploring more breakthrough cancer treatment drugs and solutions to change patients' lives and contribute to the joint construction of 'Healthy China'."

In addition to pancreatic cancer indications,AbraxanePreviously approved in China for the treatment of metastatic breast cancer that has failed combination chemotherapy or breast cancer recurring within 6 months after adjuvant chemotherapy (unless clinically contraindicated, prior chemotherapy should have included an anthracycline anticancer drug).

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[1] Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2020). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.fr/today. accessed [13 Dec 2023].
[2] Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013;369(18):1691-1703.
[3] Safety and Efficacy Study of Nab-paclitaxel Plus Gemcitabine in Chinese Patients with Metastatic Pancreatic Cancer (PANC-001). ClinicalTrials.gov ID NCT02017015. U.S. National Library of Medicine, 2016. https://clinicaltrials.gov/study/NCT02017015  (accessed 2023-12-07).
[4] 2022 Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Pancreatic Adenocarcinoma, 2022.
[5] NCCN. NCCN Clinical Practice Guidelines in Oncology – Pancreatic Adenocarcinoma, Version 2.2023.
[6] Breast Cancer Study Group of the Chinese Medical Doctor Association Oncology Physician Branch, International Medical Exchange Branch of the Chinese Anti-Cancer Association. Chinese Expert Consensus on Albumin-Bound Paclitaxel in the Treatment of Breast Cancer [J]. Chinese Journal of Oncology, 2023, 45(3): 203-211.