At BMS, we work with physicians/investigators to make investigational products available to patients with life-threatening diseases that have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. When contacted by a treating physician, BMS will consider requests for providing early patient access to Nivolumab in pediatric patients exhibiting a high mutational load.
Choosing to participate in an early patient access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join an early patient access program. To learn more about early patient access programs, your doctor may contact BMS using the information provided below.
Biological: Nivolumab
Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody approved by the US Food and Drug Administration (FDA) on an "accelerated" basis for some types of cancer. Please contact your physician for more details.
Other Name: Opdivo
Other Name: BMS-936558
Specific eligibility criteria must be met for access outside of a clinical trial.
These inclusion criteria include: - The illness must be serious or life threatening - There are no other viable options (including approved products or active clinical trials) - There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on what is known at the time - Other defined inclusion/exclusion criteria could be applicable.
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb