November 9, 2022 -- Merck announces that its PD-1 inhibitor, Parbolizumab (trade name: Kerida ®️) has been approved by the National Medical Products Administration of China (NMPA) to combine chemotherapy with neoadjuvant therapy and continue parbolizumab monotherapy after surgery for the treatment of early high-risk triple negative breast cancer (TNBC) patients with tumor expression PD-L1 (combined positive score (CPS) ≥20) by a well-validated test. The approval of this new indication is based on data from the Phase III KEYNOTE-522 study.
This is the 10th indication approved for pabolizumab in China:
① Second-line treatment of advanced melanoma
② Advanced NSCLC with PD-L1 expression ≥1% and no EGFR/ALK mutation is treated with first-line treatment
③ Combined first-line chemotherapy for advanced non-squamous NSCLC without EGFR/ALK mutation
④ Combined with first-line chemotherapy for advanced squamous NSCLC
⑤Second-line treatment of esophageal cancer
⑥ First-line treatment for advanced head and neck squamous cell carcinoma with CPS≥20
⑦ First-line treatment of MSI-H/dMMR colorectal cancer
⑧ first-line treatment of esophageal cancer
⑨ Second-line treatment of hepatocellular carcinoma
⑩ First-line treatment for early high-risk triple negative breast cancer (TNBC) with CPS≥20
Breast cancer is one of the common malignant tumors in women, the incidence of which ranks the first among female malignant tumors, seriously endangers the physical and mental health of women. Triple negative breast cancer (TNBC) is a breast cancer subtype with negative expression of estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor-2 (HER-2), and has the worst prognosis among all breast cancer subtypes. TNBC tends to occur in women under the age of 40. 4, TNBC is usually more invasive, prone to early recurrence and metastasis, and has a poor prognosis. The risk of recurrence of TNBC reaches its peak within 1 to 3 years after diagnosis, and the risk of death within 5 years is also higher than that of other types of breast cancer, which brings a great disease burden to patients.
The approval of this new indication of pabolizumab in China opens a new journey for tumor immunotherapy in the field of breast cancer, which is expected to bring new options and hope to more patients and families.
