![]() ![]() The agency will update patients and health care professionals when new information is available. The opioid epidemic is the deadliest drug crisis in American history. 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. the efficacy of Orbis in a clinical setting on OUD patients. FDA has also suspended enrollment in other ongoing Pepaxto clinical trials. According to the MHRA, the extended licence offers a novel treatment option for early-stage NSCLC patients, an area of significant unmet need. Orbis Clinical’s pharmacovigilance staffing solutions provide highly qualified consultants within drug safety, pharmacovigilance, and risk management to enhance the skills of existing teams. 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 Clinical’s pharmacovigilance staffing solutions provide highly qualified consultants within drug safety, pharmacovigilance, and risk management to. 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. ![]() efficacy, safety, clinical pharmacology) and overall. ![]() 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. Project Orbis is a program coordinated by the US Food and Drug Administration (FDA). ![]()
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