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Japan approves Merck's Keytruda to treat breast and colorectal cancer

 Last Update: 2021-09-13
 Source: Internet
 Author: User

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Recently, Merck’s blockbuster oncology drug Keytruda (pembrolizumab) has won two more regulatory victories (breast cancer and colorectal cancer) in Japan.

According to news, the Pharmaceuticals and Medical Devices Agency of Japan (PMDA) has currently approved Merck’s Keytruda for inoperable or relapsed PD-L1-positive, hormone receptor-negative, and human epidermal growth factor receptor (HER2)-negative breast cancer patients

In the randomized, placebo-controlled phase 3 KEYNOTE-355 (NCT02819518) trial, compared with the placebo combined chemotherapy group, the risk of disease progression or death in the Keytruda combined chemotherapy group was significantly reduced by 35%, and progression-free survival (PFS) Showing a statistically significant and clinically significant prolongation (9.

The second indication approved by Merck Keytruda in Japan is colorectal cancer.

In the open-label phase 3 KEYNOTE-177 (NCT02563002) trial, 307 patients with MSI-H or dMMR, unresectable or metastatic CRC were randomly assigned.

Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that improves the ability of the patient's immune system to detect and fight tumor cells

It is reported that Keytruda has brought Merck’s sales of more than 8 billion U.

Reference source: Merck's Keytruda gains two more approvals in Japan

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