Olema Oncology is committed to providing safe, fair, and sustainable patient access to its investigational compounds at different stages of lifecycle development. Olema is currently planning and conducting clinical trials to assess the potential safety, tolerability, and efficacy of OP-1250, which is an investigational compound.
Expanded access and compassionate use programs allow patients to gain access to investigational compounds outside of a clinical trial. Under the 21st Century Cures Act, the manufacturer of a drug for a serious disease or condition may provide the drug to eligible patients under certain conditions.
In order to ensure appropriate access to OP-1250 and to safeguard the welfare of clinical trial subjects and potential patients, Olema first needs to confirm that OP-1250 is safe, tolerable, and effective through controlled clinical trials. We believe the best way to make OP-1250 available to patients is by enrolling and completing all of our clinical trials and pursuing a regulatory approval pathway, thus enabling the broader population to get access.
Olema is not making OP-1250 available on an expanded access basis at this time. Olema believes that participation in our clinical trials is the most appropriate way to access OP-1250. Additional information on Olema clinical trials can be found at https://www.clinicaltrials.gov. Our expanded access guidelines will be continuously reassessed, and any updates will be provided on our website. Olema reserves the right to update or revise its expanded access policy at any time. For information on any updates or changes to Olema’s expanded access policy and current clinical studies, please visit www.clinicaltrials.gov or www.olema.com. Olema’s publication of this current policy or any future policy shall not serve as a guarantee of access to any specific investigational compound by any individual.
Currently, participation in clinical trials is the only way for patients to gain access to OP-1250. As more clinical data on the safety and efficacy of this investigational therapy becomes available, we will review and update our policy on Expanded Access.