The Ministry of Food and Drug Safety issued a warning to Ono Pharma Korea for late reporting of the grave and unexpected adverse reactions during a clinical trial on nivolumab, a medication to treat cancer.
According to the ministry, the pharmaceutical firm reported two days later that a patient, participating in the trial on “ONO-4538” (ingredient: nivolumab), was hospitalized due to urinary tract infection and pneumonia.
The patient is receiving treatment at the hospital. The ministry issued the warning to the drugmaker for breaching Article 34 of the Pharmaceutical Affairs Act.
The Pharmaceutical Affairs Act stipulates that in the case of a serious and unexpected drug adverse reaction, a test client must promptly report it to the clinical trial assessment committee within 15 days of learning it.
Clinical trials or changes requiring a quick reporting to the committee include a test conducted differently from the original plan to eliminate immediate risk to the patients, a change that could increase the risk to the patient or could significantly affect the study, severe unexpected drug adverse reactions, and new information that may adversely affect the safety of the patient or the study.
Nivolumab is immunotherapy sold under the brand name of Opdivo in Korea.
Ono Pharma Korea is conducting the phase-3 trial to confirm its efficacy in various carcinomas, including metastatic urothelial carcinoma, metastatic squamous cell esophageal cancer, non-squamous non-small cell lung cancer, gastric cancer, recurrent or metastatic head and neck squamous cell carcinoma, and hepatocellular carcinoma.
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