Corvus Expanded Access Policy

Corvus Pharmaceuticals, Inc (Corvus), a clinical-stage company is developing an investigational small molecule soquelitinib, a novel first-in-class Interleukin-2-inducible T cell kinase (ITK) inhibitor for treatment of patients with relapsed/refractory peripheral T-cell lymphomas (R/R PTCL). We are focused on conducting the necessary clinical trials to evaluate the safety and efficacy of soquelitinib and thereby gain regulatory approvals from FDA or other regulatory authorities as quickly as possible to make soquelitinib available broadly to patients with this serious or life-threatening condition. 

Corvus believes that participating in clinical trials is the best way for patients to access Corvus’ investigational medicines prior to approval. To participate in a clinical trial, a patient must meet the eligibility criteria. These criteria are important because they help researchers identify a group of people with similar characteristics of a disease and aid with interpretation of clinical data. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe and effective therapies.

Expanded access programs, often referred to in various ways, including managed access, expanded access, early access, preapproval access, compassionate use and emergency use are potential pathways for patients to receive investigational drugs that are not yet approved by the FDA or other regulatory authorities but may be beneficial for patients with serious or life-threatening conditions. Under these programs, patients who are unable to participate in a clinical trial may potentially receive the investigational drug outside of a clinical trial. Currently, Corvus does not offer an expanded access program. We believe that access to our investigational product candidates should be limited to clinical trials at this time. Corvus encourages awareness of and participation in our clinical trials. For more information on Corvus’ currently enrolling clinical trials, please visit www.clinicaltrials.gov or contact Corvus at clinicaltrials@corvuspharma.com