Merck and Ethical Kidney Cell Carcinoma Combination Therapy Receives FDA Breakthrough Therapy
January 10, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On January 9th, Eisai and Merck Pharmaceuticals announced that the US FDA has awarded ECOVIMA® (lenvatinib), a multi-receptor tyrosine kinase inhibitor, to MODTRUDA® (pembrolizumab) for advanced and/or Or metastatic renal cell carcinoma (RCC) treatment for breakthrough therapy. The joint treatment of LENVIMA and Keytruda was jointly developed by Japan Eisai and Merck. This is LENVIMA's second breakthrough therapy designation and the 12th time for KeyTruda to be awarded a breakthrough therapy.
Breakthrough therapy is a special review path that the US FDA aims to accelerate the development and review of serious or life-threatening drugs. The initial clinical evidence of the drug being granted for this designation must demonstrate an advantage over existing treatment options. Drugs that are awarded breakthrough therapy receive special guidance and priority in the clinical development and registration review phase.
The above-mentioned combination therapy for RCC treatment breakthrough therapy was based on Study 111 RCC cohort study data, Study 111 is a multi-center, open-label clinical Phase 1b/2 trial in the US and Europe to evaluate lenvima and Keytruda is used in combination to treat the safety of patients with selected solid tumors.
Dr. Takashi Owa, Vice President and Chief Medical Creation Officer of the Eisai Tumor Group, said: "This award for breakthrough therapy represents the FDA's recognition of the potential of lenvima plus Keytruda in the treatment of advanced and/or metastatic renal cell carcinoma patients. Working closely with Merck and the FDA to accelerate the development of this clinical project and hope to provide another important treatment option for patients with treatment needs."
Dr. Roy Baynes, Senior Vice President and Head of Global Clinical Development and Chief Medical Officer of Merck, said: "The FDA's identification of LENVIMA and Keytruda for the treatment of advanced and/or metastatic renal cell carcinoma has provided us with an effort to Patients have an important potential treatment option and we will continue to work to understand Keytruda's full potential for the treatment of cancer and other diseases."
The primary goal of the Phase 1b of the Study 111 trial was to determine the maximum tolerated dose for patients who were not surgically resectable (renal cell carcinoma, endometrial cancer, non-small cell lung cancer, urothelial carcinoma, squamous cell head and neck). Cancer and melanoma). The clinical phase 2 was based on a 20 mg LENVIMA / day + 200 mg KEYTRUDA / 3 week dose determined in Section 1b. The study was performed on a solid tumor patient who had previously received a 0-2 line system. The primary end point was after treatment initiation. The 24-week objective response rate, secondary study endpoints included target response rate, disease control rate, progression-free survival, and duration of response. Currently, clinical phase 2 trials are ongoing and endometrial cancer cohort studies are being enrolled. (Sina Pharmaceutical Compilation / David)
Article reference source: https://finance.yahoo.com/news/eisai-merck-receive-breakthrough-therapy-114500187.html
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