AnHeart Therapeutics is a clinical stage biopharmaceutical company committed to developing novel precision oncology therapeutics to improve the lives of cancer patients. We strive to bring innovative therapies to patients by conducting clinical trials globally and obtaining marketing approval by the US Food and Drug Administration (FDA) and health authorities in other countries and regions. Before our drugs become commercially available to patients, we conduct a series of clinical studies to better understand how the drugs work and obtain clinical evidence that they are safe and effective for treatment of the intended disease conditions.
AnHeart is currently conducting clinical studies with our investigational drug taletrectinib (AB-106) which has not yet been approved by the US FDA or any other health authorities in other countries and regions for commercial sale. Taletrectinib has been granted Breakthrough Therapy designation by the FDA for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC), who are either tyrosine kinase inhibitor (TKI) treatment naïve or previously treated with crizotinib (https://www.anhearttherapeutics.com/news/press-releases/080322/).
AnHeart believes participation in clinical trials is the most appropriate way to receive investigational drugs and to maximize the potential for the intended clinical benefits for patients seeking access before the drugs are approved by health authorities. Therefore, at this stage we do not offer any Expanded Access program for access to our investigational drug taletrectinib outside the clinical trials.
The relevant information regarding the Phase 2 Global Study (TRUST-II) of taletrectinib is available at https://clinicaltrials.gov/ct2/show/NCT04919811.
For general information about publicly and privately supported clinical trials conducted around the world, please visit: https://clinicaltrials.gov and search by company, disease or medicine for further information on clinical studies.
For additional information about the FDA's current Expanded Access policies, requirements for enrolling in Expanded Access programs, and steps you can take to get more information, please visit: https://www.fda.gov/news-events/public-health-focus/expanded-access
In accordance with the 21st Century Cures Act, AnHeart may update or revise this policy at any time.