However, we also recognize that, when participating in a clinical study is not possible, patients facing serious or life-threatening conditions may seek access to investigational drugs outside of a clinical study setting.
Consistent with applicable laws and regulations, Kura Oncology may provide patients with access to investigational drugs through Expanded Access/Compassionate Use Programs when there is sufficient evidence of the safety profile and clinical activity of the investigational drug to support its use in a particular circumstance. The patient’s physician will perform an assessment as to the patient’s suitability for the treatment.
At this time, Kura Oncology is only providing expanded access to our investigational drugs as follows:
- Tipifarnib for eligible ADULT patients with HRAS mutations or Peripheral T-Cell Lymphoma (PTCL) in the United States as permitted under local laws and regulatory requirements. Additional information regarding access to our investigational drug tipifarnib outside of clinical studies can be found at clinicaltrials.gov (NCT04809233).
- Ziftomenib for eligible ADULT patients with Acute Lymphoblastic Leukemia (ALL) with appropriate mutations, or patients with Acute Myeloid Leukemia (AML) with NPM1 mutations and without KMT2A rearrangements, in the United States as permitted under local laws and regulatory requirements. Additional information regarding access to our investigational drug ziftomenib outside of clinical studies can be found at www.clinicaltrials.gov (NCT05738538).