Difolta, drugs that recently completed Phase I/II trials

Difolta, Istodax, Bavencio, and Kyprolis are four oncology drugs that received conditional approval in Japan between 2016 and 2017.The overall response rate of each drug was at least 23% during Phase I/II trials.OverviewUpon conditional approval from Phase II data of regenerative medicine in Japan, certain drugs are permitted for use before completing Phase III trials. The following four oncology drugs have completed both Phase I and II trials, and have conditional approval as of 2016 or 2017 for use: Difolta, Istodax, Bavencio, and Kyprolis. Below you will find a breakdown of each drug, the manufacturer, year of approval, and case statistics for each. DIFOLTAThe oncology drug Difolta was given conditional approval for use in Japan as of July 3, 2017. This drug is a 20 mg injection and contains the active ingredient Pralatrexate, meant for treating refractory peripheral T-cell lymphoma. Manufactured by Mundipharma, the drug began Phase I/II clinical trials in 2013. In Japan, 100% of patients had a response to Difolta in Phase I, and a total of 45% patients had a response over the entire length of the Phase I/II trial period.ISTODAX?Istodax is an 10 mg injection oncology drug meant for treatment of peripheral T-cell lymphoma. Manufactured by the Celgene Corporation, it was given conditional approval in Japan on July 3, 2017, and contains the active ingredient Romidepsin. The drug completed Phase I trials for Hematological malignancies, and Phase I/II for Myeloma, Lymphoma, and Leukemia. The overall response rate of this drug during the PhaseI/II trials was 44%. Trials were completed with 9 mg (Phase I) and 14 mg (Phase II) to determine an average of 10 mg per dose due to the high toxicity of the drug. BAVENCIO?Bavencio is a 200 mg injection oncology drug that was given conditional approval for use in Japan on September 27, 2017. The drug contains the active ingredient Avelumab and is intended for the treatment of Merkel Cell Carcinoma (MCC). Bavencio completed Phase II trials for MCC and is administered intravenously for 60 minutes every 2 weeks until disease regression is visible, or until toxicity levels are unacceptable. While there are no statistics provided on the response rate of the drug, the fact that it received conditional approval implies that it is likely a successful drug. KYPROLISOncology drug Kyprolis was given conditional approval for use in Japan on July 4, 2016. This drug comes in both 10 mg and 40 mg intravenous injections and contains the active ingredient Carfilzomib. Manufactured by Ono Pharmaceutical Co. Ltd., Kyprolis is intended for treating Refractory Multiple Myeloma. The overall response rate for the drug was 22.9% over 7.8 months. Phase II trial for Kyprolis was completed for patients with renal issues.  7% of the 526 trial patients died within 30 days of the last dose of Kyprolis. CONCLUSIONDifolta, Istodax, Bavencio, and Kyprolis are different oncology drugs that recently completed Phase I/II trials in Japan and have received conditional approval for use on patients. While they each treat a different form of cancer, each drug was relatively successful for trial patients. These drugs have not yet been approved for or completed Phase III trials, and have all received their approvals within 2016 or 2017.

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