Pfizer China announced the China National Drug Administration (CNDA) has granted approval of IBRANCE (palbociclib) on July 31st, the first cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor, for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women.
"We are very happy and proud to have received approval of Ibrance in China. Ibrance is the first CDK4/6 inhibitor development by Pfizer, today we are able to bring this innovation to Chinese advanced breast cancer patients to provide new hope and a new treatment option to significantly prolong their PFS and improve their life quality, which benefits the patient's family and society as well," said Wu Kun, China Country Manager of Pfizer Innovative Health.
The 5-year survival rate of advanced BC patients is only 20%, and no significant improvement in treatment solutions has been made in the past 10 years.
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Breast cancer is one of the most common cancers in women worldwide. In 2015, 272,000 women in China were diagnosed with breast cancer, and 70,000 women died of breast cancer. Each year, 1 in 10 newly-found cases is diagnosed as advanced breast cancer. Even among early breast cancer patients who have received surgical treatment and undergone standard therapy, 30-40% will later recurrence into advanced breast cancer. Public awareness and understanding of advanced breast cancer remains low. In 2016, Pfizer and the European Oncology Society jointly released the Global Status of Advanced/Metastatic Breast Cancer 2005 – 2015 Decade Report, which found that in U.S., 61% of people know little about advanced breast cancer, and 48-76% of surveyed populations in 14 countries mistakenly assume that advanced breast cancer can be cured.
Different to early breast cancer treatment, for which there exist a variety of treatment methods, there has been no significant development in treatment solutions for advanced breast cancer in the past 10 years. The median overall survival for patients with advanced breast cancer is only 2-3 years, with only 20% 5-years survival rate. Innovative therapies are urgently needed.
Ibrance is the world's first CDK 4/6 selective inhibitor, effectively prolonging the median PFS by 10 months.
Ibrance is an oral inhibitor of cyclin-dependent kinases (CDKs) 4 and 6. CDKs 4 and 6 are key regulators of the cell cycle that triggers cellular cycle progression. CDK 4/6 is over-expressed in many kinds of cancer cells and causes loss of cell cycle control, which is considered a key cancer indicator. Ibrance is the world's first CDK 4/6 inhibitor, which restores control of the cell cycle and thus blocks the proliferation of tumor cells. In 2013, Ibrance received the Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced breast cancer. In 2015, Ibrance received FDA accelerated approval for the treatment of advanced breast cancer. The US National Comprehensive Cancer Network (NCCN) Panel has included the combination of palbociclib with letrozole as a first-line endocrine therapy option for postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer.
Research indicates that Ibrance in combination with letrozole for the treatment of patients with HR+/HER2- resulted in median PFS of 24.8 months while 14.5 months in letrozole monotherapy arm. Compared to letrozole single-agent treatment, Ibrance in combination with letrozole treatment prolonged the PFS for patients with advanced breast cancer by 10 months.
To date, Ibrance has been approved for market entry in 86 countries and regions worldwide, and China mainland is the 87th.
"As a leading pharmaceutical company in China, Pfizer strives to provide cancer patients with the latest treatments in pursuit of maximum benefits, which is an active response to government's 'Healthy China 2030' initiative and Pfizer's commitment of Working Together for a Healthier China," said Wu Kun, China Country Manager of Pfizer Innovative Health. "We are grateful to the Chinese government for adopting a broad range of measures to meet the urgent clinical needs for medication for tumor patients, and I'm thankful to every officer involved in approving Ibrance. This joint effort will ensure that Chinese advanced breast cancer patients experience the benefits from Ibrance sooner, enabling them to receive better overall treatment and enjoy a higher quality of life."