(Bladder Cancer) FDA Approves OPDIVO
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
- February 9, 2017
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A joint press release from Bristol-Myers Squibb (USA) and Ono Pharmaceutical (Japan) announced that Opdivo has received FDA approval for urothelial carcinoma. The release also noted that the approval covers bladder cancer patients. The eligible population includes patients with metastatic urothelial carcinoma, including bladder cancer, who have received prior platinum-based therapy and demonstrated good efficacy outcomes. This clinical trial, called CheckMate-275, enrolled 270 patients with a dosage of 3 mg/kg; the recommended dose is 240 mg, though adjustments are required based on the patient's condition and tolerability. The median age of volunteers was 66 years (range: 38–90 years); 29% of patients had received two or more prior systemic therapies. Notably, this clinical trial did not require patients to have detectable PD-L1 expression. This trial was previously presented at ESCO 2016. According to the press release, the response rate for Opdivo was 19.6%. Related information can be confirmed in the press releases from Ono Pharmaceutical and Bristol-Myers Squibb.
URL: http://www.ono.co.jp/jpnw/PDF/n17_0203.pdf
Additionally, details regarding PD-L1 detection rates from the press release are provided in the screenshots below for reference.
#BladderCancer #UrothelialCancer
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