Learn more about our policy on expanded access to investigational drugs.
We’re challenging the status quo so those who live with metastatic breast cancer have the potential to feel better, longer.
We know that from the moment of diagnosis, lives are forever changed. Much progress has been made within the breast cancer treatment space. But it is not enough.
At Olema, we are inspired by people and their stories and are determined to develop safer, more effective and convenient medicines to signal in a new day for those impacted by metastatic breast cancer.
Breast cancer overview
We show up to work every day because we’re driven to impact millions of lives, helping not only people with breast cancer, but their families, caregivers, and communities.
With our lead investigational product candidate, palazestrant (OP-1250), we seek to address estrogen receptor-positive (ER+) breast cancer, which represents about 80% of all breast cancer cases. Palazestrant is a once-daily oral medicine designed to provide a more convenient and potentially more effective approach for managing ER+/HER2- breast cancer that has recurred or spread beyond the initial disease site.
- Breast cancer is the second most prevalent cancer worldwide, with nearly 2 million new diagnoses each year. In 2024, the American Cancer Society estimates that there will be approximately 310,720 new cases of female breast cancer and about 42,250 deaths from metastatic breast cancer in the United States.
- Approximately 6 to 10% of breast cancer patients present with metastatic disease at diagnosis and a further 20 to 30% of patients initially diagnosed with early-stage disease ultimately develop metastatic disease.
- The current five-year survival rate for patients with ER+ metastatic breast cancer is approximately 30%.
Current clinical trials
Before a new therapy can be made available to the general public, multiple studies involving patient volunteers must be conducted to evaluate the safety and effectiveness of the therapy.
These studies, referred to as clinical trials, are regulated by the Food and Drug Administration (FDA) in the United States and by similar regulatory agencies worldwide.
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer (OPERA-01)
A Phase 1b Study in Combination With a CDK4/6 Inhibitor or With a PI3K Inhibitor
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
Policy on expanded access to investigational drugs
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 palazestrant (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 palazestrant and to safeguard the welfare of clinical trial subjects and potential patients, Olema first needs to confirm that palazestrant is safe, tolerable, and effective through controlled clinical trials. We believe the best way to make palazestrant 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 palazestrant available on an expanded access basis at this time. Olema believes that participation in our clinical trials is the most appropriate way to access palazestrant. 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 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 palazestrant. 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.