Heavy! Lilly's new breast ® (Abesili tablets) approved in China!

Lilly Pharmaceuticals recently announced that its new anti-tumor drug ® (Abesili tablets) was approved by the State Drug Administration (NMPA) on December 29, 2020 for hormone-positive hormone (HR), human skin growth factor 2 (HER2) negative local late stage or metastatic breast cancer: (1) in combined with aromatase inhibitors as an initial endocrine treatment in post-menstrual female patients.
(2) in a joint use with fluorovis groups in patients who had previously received endocrine therapy and developed the disease.
Chinese scholars led the international multi-center clinical study and verified the efficacy and safety of selecting ® (Abesili tablet) combined endocrine therapy for patients with advanced breast cancer in China®.
The study was led by Professor Jiang Zefei of the Fifth Medical Center of the Chinese People's Liberation Army General Hospital and Professor Hu Xichun of Fudan University-affiliated Oncology Hospital, with the participation of 45 centers from China, India, Brazil and South Africa, including 28 research centers in China.
the strict threshold for demonstrating efficacy during pre-planned in-period analysis of THEMONARCH plus.
A confirmed that Abesili combined nonsteroidal aromatase inhibitors had significant statistically and clinically disease-free progression lifetime (PFS not reached, placebo combined NSAI group median PFS was 14.73 months; HR: 0.499; 95% CI, 0.346 - 0.719; p=0.0001）。
queue B confirmed that the Abesiliga fluovis group had extended the medium PFS 5.88 months compared to the fluvis group monodride treatment and had significant clinical significance (11.47 months vs. placebo plus fluorovis group 5.59 months; HR s 0.376; 95% CI, 0.240 - 0.588; P<0.0001）。
two queues, the benefits of Abesili were generally consistent among predefined subgroups.
Abesili combined endocrine therapy showed safety characteristics consistent with previous studies, good tolerance in the population, including patients with advanced breast cancer in China, and common adverse events that can be monitored and managed.
the results of this in-period analysis were first published in the European EsMO in 2019 and published in Therapeutic Advances in Medical Oncology in October 2020.
MONARCH plus is the first and only international multi-center Phase III clinical study to confirm the clinical benefits of CDK 4 and CDK 6 inhibitors in chinese patient-based women with HR-plus, HER2-advanced breast cancer, and thanks to the significant contributions made by researchers, health care workers, patients and their families in China and three other countries.
only ® (Abesili tablets) is expected to become China's vast number of HR- and HER2-advanced breast cancer patients treatment of new choice breast cancer is a threat to the health of Chinese women's first major malignant tumor.
according to the International Agency for Research on Cancer, there will be about 416,000 new breast cancer cases and about 117,000 deaths in China in 2020, accounting for about 17.1% of global breast cancer deaths.
of the various subtypes of advanced breast cancer, HR-plus, HER2-most common, accounting for about 60%.
, however, the complexity of the disease is a huge challenge for the treatment of HR-plus, HER2-advanced breast cancer, and new treatment options are urgently needed to improve the effectiveness of treatment and prolong the lives of patients.
about advanced breast cancer breast cancer is the world's highest incidence and death of malignant tumors in women.
about 3-8% of breast cancer patients are terminally breast cancer at the beginning of diagnosis.
30-40% of patients with early breast cancer still develop advanced breast cancer after surgery and postoperative treatment.
4 once progressed into advanced breast cancer, patients often can not be cured, the five-year survival rate of only about 20%, the total survival time of the middle is only 2 to 3 years.
.6) The MONARCH plus study MONARCH plus is a randomized, double-blind, international multi-center Phase III clinical study conducted in women with predominantly Chinese patients with HR-HER2-post-menopletic advanced breast cancer.
The study assessed the efficacy and safety of abesili combined nonsteroidal aromatase inhibitors (lactazine or anatrophic) as a placebo combined nonsteroidal aromatase inhibitor at the time of initial treatment, and abesili combined fluvis groups compared to placebo combined fluovirs group therapy after progress in endocrine therapy.
About Option ® (Abesili Tablets) Option ® (Abesili Tablets) is an inhibitor of cell cycle protein-dependent kinases (CDK)4 and 6 that are activated by binding to cell cycle protein D.
In estrogen-positive (ER-plus) breast cancer cell line, cell cycle proteins D1 and CDK4 and 6 promote phosphate of retinal cytoblastoma protein (Rb) and accelerate cell cycle processes and cell proliferation.
in-body, continuous exposure to Abesili inhibits RB phosphorylation and blocks the progression of cell cycles from G1 to phase S, leading to cell aging and apoptosis (cell death).
-® (Abesili tablet) is Lilly's first solid oral drug to be produced in a faster and more efficient "continuous production" mode.
"continuous production" is an advanced new production model in the pharmaceutical industry, and Lilly was one of the first companies to use the technology.
About Lilly Pharmaceuticals Lilly Pharmaceuticals is a leading global pharmaceutical company dedicated to improving human health through innovation.
more than a century ago, the company's founders were committed to producing high-quality medicines to meet real medical needs.
today, we remain obsessive about this mission and work on that basis.
, our employees strive to develop drugs that can make a difference in human life and make them available to patients who really need them.
, we are committed to improving public understanding of disease and better disease management, while giving back to the community through our commitment to philanthropy and volunteering.
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: . . . Jiang Z, et al.2019 ESMO Abstract LBA25. [2] Zhang QY, et al. Ther Adv Med Oncol. 2020; 12:1-14[3] Global Cancer. IARC.2020.Deluche E, et al. Eur J Cancer. 2020; 129:60-70 The consensus of experts in the treatment of advanced breast cancer in China. Chinese Medical Journal.2018; 98 (2): 87-90: National Cancer Expert Committee of the Center for Quality Control of Cancer, China Anti-Cancer Association Breast Cancer Professional Committee, China Anti-Cancer Association Oncology Clinical Research Professional Committee. China's Guidelines for the Standard Diagnosis and Treatment of Advanced Breast Cancer (2020 Edition) Chinese Journal of Oncology, 2020, 42 (10): 781-797 Lilly Source: Lilly Copyright Notice: All text, images and audio and video materials on this website that indicate "Source: Mets Medicine" or "Source: MedSci Original" are owned by Metz Medicine and may not be reproduced by any media, website or individual without authorization.
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