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TextPharmaceutical Guanlan
On January 6, Eli Lilly and Company announced that its new anti-tumor drug Abeccil (trade name: Weizhe) was approved by China's National Medical Products Administration (NMPA) in combination with tamoxifen or aromatized Endocrine therapy such as enzyme inhibitors is suitable for adjuvant therapy in adult patients with HR-positive, HER2-negative, lymph node-positive, high recurrence risk and Ki-67≥20% early breast cancer
.
According to a press release, abeccil has thus become the first and only CDK4/6 inhibitor approved for patients with early breast cancer in mainland China
.
Breast cancer is the most common cancer in women worldwide
.
It is estimated that 90% of breast cancers are diagnosed at an early stage
.
Abeccil is an inhibitor of cyclin-dependent kinases (CDKs) 4 and 6, activated by binding to cyclin
D.
It inhibits the phosphorylation of Rb and blocks the progression of cells from the G1 phase to the S phase of the cell cycle, resulting in cellular senescence and apoptosis
.
According to the press release, the approval of the new indication is based on the results of a randomized multicenter Phase 3 clinical study called monarchE
.
The data show that in adult patients with HR-positive, HER2-negative, node-positive, high-risk of early breast cancer, and Ki-67 ≥ 20%, compared with standard endocrine therapy, abeccil combined with standard endocrine therapy significantly reduces high-risk early breast cancer.
The recurrence risk of cancer patients was 37%, and the 3-year invasive disease-free survival (IDFS) rate was 7.
References:
[1] Eli Lilly’s new breast cancer drug Weize® (Abecili Tablets) added early breast cancer indications, creating a new era of adjuvant therapy for HR+, HER2- early breast cancer patients at high risk.
(Original abridged)