EA Policies for Single Patient:
At Dizal, we aspire to discover and develop differentiated therapeutics for the treatment of cancer and immunological diseases.
Sunvozertinib (DZD9008)
Sunvozertinib is an oral EGFR tyrosine kinase inhibitor (TKI). In the United States and China, sunvozertinib has been granted accelerated/conditional approval for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. It is currently being investigated as a single agent in phase 3 clinical trials for the first-line treatment of Non-Small Cell Lung Cancer (NSCLC) patients with EGFR Exon20ins mutation. We are conducting clinical trials aiming at gaining regular approval to make sunvozertinib available to all eligible patients as quickly as possible. As such, we believe participation in our clinical trials is the most appropriate way to access sunvozertinib at this stage of development. Information about our clinical trials, including eligibility criteria and locations, is available at clinicaltrials.gov.
Dizal understands the interest of patients in accessing sunvozertinib outside of clinical trials and prior to regulatory approval for potentially life-threatening diseases. At this time, Dizal is not able to grant requests for expanded access to sunvozertinib or its investigational therapies.
Golidocitinib (DZD4205, AZD4205)
Golidocitinib is an oral, potent, highly selective Janus kinase 1 (JAK1) inhibitor. In China, golidocitinib has been granted conditional approval for the treatment of adult patients with relapsed or refractory peripheral T cell lymphoma (r/r PTCL) who have received at least one prior line of systemic therapy. It is currently being investigated in a phase 3 clinical trial for the treatment of patients with r/r PTCL. We are conducting clinical trials aiming at gaining regular approval to make golidocitinib available to all eligible patients as quickly as possible. As such, we believe participation in our clinical trials is the most appropriate way to access golidocitinib at this stage of development. Information about our clinical trials, including eligibility criteria and locations, is available at clinicaltrials.gov.
Dizal understands the interest of patients in accessing golidocitinib outside of clinical trials and prior to regulatory approval for potentially life-threatening diseases. At this time, Dizal is not able to grant requests for expanded access to its investigational therapies.
Birelentinib (DZD8586)
Birelentinib is a novel oral LYN/BTK dual inhibitor with high potency and selectivity. It is currently being investigated for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (r/r CLL/SLL). We are conducting clinical trials aiming at gaining regular approval to make birelentinib available to all eligible patients as quickly as possible. As such, we believe participation in our clinical trials is the most appropriate way to access birelentinib at this stage of development. Information about our clinical trials, including eligibility criteria and locations, is available at clinicaltrials.gov.
Dizal understands the interest of patients in accessing birelentinib outside of clinical trials and prior to regulatory approval for potentially life-threatening diseases. At this time, Dizal is not able to grant requests for expanded access to its investigational therapies.
The posting of this policy by Dizal shall not serve as a guarantee of access to any specific investigational drug by any individual patient.
Dizal recognizes the need for Expanded Access Programs and will re-evaluate the status of our policy based on data from ongoing and future clinical trials. Dizal may revise this expanded access policy at any time. This posting will be updated should there be any policy change.