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On July 27, 2021, Merck (MSD) announced that the US FDA approved its blockbuster PD-1 antibody therapy Keytruda in combination with chemotherapy, as a neoadjuvant therapy before surgery, and as a single drug as an adjuvant therapy after surgery, to treat high-risk Patients with early triple-negative breast cancer (TNBC)
.
This is the 30th indication that Keytruda has been approved in the United States
It is worth mentioning that Merck also announced that Keytruda combined with chemotherapy has achieved positive overall survival (OS) results in a phase 3 clinical trial for the treatment of patients with metastatic TNBC
.
In patients with metastatic TNBC whose tumors express PD-L1 (CPS>10), the Keytruda chemotherapy combination provides a statistically significant and clinically significant improvement in overall survival compared with chemotherapy
Triple-negative breast cancer is an aggressive type of breast cancer characterized by a higher risk of disease recurrence within the first five years after diagnosis
.
Because it does not express estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (HER2), patients cannot receive targeted therapy targeting these receptors, and treatment options are limited
This approval is based on the results of a randomized, double-blind, placebo-controlled phase 3 clinical trial of KEYNOTE-522
.
The trial was conducted in 1,174 newly diagnosed patients with high-risk early stage TNBC
In addition, based on the data of KEYNOTE-522, the US FDA converted the accelerated approval of Keytruda combined with chemotherapy to treat locally recurrent unresectable or metastatic TNBC patients with tumor expressing PD-L1 (CPS ≥ 10) into full approval
Note: The original text has been deleted
Reference materials:
[1] FDA Approves KEYTRUDA® (pembrolizumab) for Treatment of Patients With High-Risk Early-Stage Triple-Negative Breast Cancer in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continue as Single Agent as Adjuvant Treatment After Surgery.
[2] KEYTRUDA Is the First Anti-PD-1 Therapy in Combination With Chemotherapy to Show Statistically Significant OS for This Patient Population.
