{"id":15214,"date":"2024-11-27T17:05:48","date_gmt":"2024-11-27T09:05:48","guid":{"rendered":"https:\/\/flcube.com\/?p=15214"},"modified":"2024-11-27T17:05:50","modified_gmt":"2024-11-27T09:05:50","slug":"sichuan-kelun-biotechs-skb264-mk-2870-approved-by-nmpa-for-triple-negative-breast-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=15214","title":{"rendered":"Sichuan Kelun-Biotech’s SKB264\/MK-2870 Approved by NMPA for Triple Negative Breast Cancer"},"content":{"rendered":"\n

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990<\/a>), a China-based biopharmaceutical company, has received market approval from the National Medical Products Administration (NMPA) for its drug sacituzumab tirumotecan (SKB264\/MK-2870). This drug is intended to treat adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have previously undergone at least two kinds of systematic treatment, including at least one for the advanced or metastatic stage.<\/p>\n\n\n\n

Global Licensing Deal and TROP2-Targeted ADC<\/strong>
Sacituzumab tirumotecan (SKB264\/MK-2870), a TROP2-targeted antibody drug conjugate (ADC), was the subject of a licensing agreement with Merck, Sharp & Dohme (MSD) in May 2022 for distribution outside Greater China. This collaboration highlights the global potential of the drug in addressing TNBC and other cancer types.<\/p>\n\n\n\n

Positive Phase III Study Results Influence NMPA Decision<\/strong>
The NMPA’s decision was influenced by the positive outcomes of the randomized, controlled Phase III OptiTROP-Breast01 study. In this study, sacituzumab tirumotecan demonstrated statistically and clinically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to chemotherapy.<\/p>\n\n\n\n

Pending Regulatory Decisions in China<\/strong>
While the drug has been approved for TNBC, sacituzumab tirumotecan is still awaiting regulatory decisions in China for two additional indications. These include its use as a monotherapy for locally advanced or metastatic EGFR mutant non-small cell lung cancer (NSCLC) that has progressed after EGFR-TKI treatment, and for the treatment of locally advanced or metastatic EGFR mutant NSCLC in patients previously treated with EGFR-TKI and platinum-based chemotherapy.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

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