9/9/2023 0 Comments Orbis clinical drug safety![]() The agency will update patients and health care professionals when new information is available. Patients receiving clinical benefit from Pepaxto may continue treatment in the OCEAN trial provided they are informed of the risks and sign a revised written informed consent.įDA continues to evaluate the OCEAN trial results and may hold a future public meeting to discuss these safety findings and explore the continued marketing of Pepaxto. Orbis Clinical’s pharmacovigilance staffing solutions provide highly qualified consultants within drug safety, pharmacovigilance, and risk management to. FDA has also suspended enrollment in other ongoing Pepaxto clinical trials. Project Orbis was designed as a global collaborative regulatory review programme led by the US Food. ![]() The manufacturer, Oncopeptides AB, was required to conduct the OCEAN trial as a post-approval requirement under the accelerated approval program.ĭue to the detrimental effect on overall survival in the OCEAN trial, FDA is requiring the manufacturer suspend enrollment in the trial. Orbis, a multinational oncology review programme, some 15 days before market authorisation in the EU. In February 2021, FDA approved Pepaxto under Accelerated Approval for use in combination with dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease was refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. Patients currently receiving Pepaxto should also discuss with their health care professional the risks and benefits of receiving Pepaxto. ![]() The trial compared Pepaxto with low-dose dexamethasone to pomalidomide with low-dose dexamethasone in patients with relapsed or refractory (resistant) multiple myeloma following 2-4 lines of prior therapy and in patients who were resistant to lenalidomide in the last line of therapy.įDA encourages health care professionals to review patients’ progress on Pepaxto and discuss the risks of continued administration with each patient in the context of other treatments. Life Sciences Solutions Orbis Clinical is a leading global recruiting partner to the life sciences industry we have been driving the success of our clients, consultants, and employees in staffing and consulting services since 2004. FDA is alerting patients and health care professionals that a clinical trial ( OCEAN, Study OP-103) evaluating Pepaxto (melphalan flufenamide) with dexamethasone to treat patients with multiple myeloma showed an increased risk of death. Orbis Clinical 5,801 followers on LinkedIn. ![]()
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