AstraZeneca Inc., (AZ, NASDAQ: AZN), a UK-based pharmaceutical giant, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its Zoladex (goserelin sustain-released implant) 10.8mg. This new dosage form is intended for use in premenopausal and perimenopausal women with breast cancer who can be treated with hormone therapy.
Zoladex is a synthetic gonadotropin-releasing hormone analog (GnRHa) that can inhibit the secretion of pituitary gonadotropins when used long-term, thereby reducing the level of estradiol (E2) in female serum and inhibiting the growth of estrogen-sensitive tumors. Previously, its 3.6mg dosage form was approved for prostate cancer, breast cancer, and endometriosis in China, and the 10.8mg dosage was approved for prostate cancer in China in 2011.
The approval is supported by positive results from a national, multi-center, real-world study of Ezreal, which compared the inhibitory effects of the 10.8mg and 3.6mg dosage forms of Zoladex on E2 levels in premenopausal and perimenopausal HR+ breast cancer patients. The study demonstrated that at week 12 ± 4, 99.1% of patients in the group receiving 10.8mg of Zoladex experienced a decrease in E2 levels to postmenopausal levels. The group receiving 3.6mg of Zoladex had a 95.3% decrease, with a difference of 3.8% between the two formulations (95% CI: 0.6%, 8.1%). All subgroup analyses, including those based on age (≤ 45/>45 years) and previous chemotherapy (yes/no), as well as all sensitivity analyses for the primary endpoint, were consistent with the results of the primary analysis. The Ezreal study confirmed that the 10.8mg dosage form and the 3.6mg dosage form of Zoladex are non-inferior in Chinese HR+ premenopausal and perimenopausal breast cancer patients, indicating they have the same effect in inhibiting E2 levels.- Flcube.com
