The Food and Drug Administration granted a priority review to Blincyto for the treatment of early-stage CD19-positive B-cell acute lymphoblastic leukemia.
The Food and Drug Administration (FDA) granted a Priority Review for a supplemental biologics license application to Blincyto (blinatumomab) for the treatment of patients with early-stage, CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL), according to Amgen, the manufacturer of the drug.
The priority review is based, in part, on findings from the phase 3 E1910 trial which was conducted by the National Cancer Institute, ECOG-ACRIN Cancer Research Group.
The trial compared overall survival (OS; time from treatment until death of any cause) between two groups of patients: the first group was randomly assigned to receive Blincyto plus chemotherapy, while the second group received chemotherapy alone. The main goal of the trial was to determine OS in patients in each group with minimal residual disease (MRD) negativity after induction chemotherapy, which essentially means that clinicians could not find cancer DNA remnants in the patients’ blood after they underwent therapy meant to eradicate the disease.
The researchers on the trial are also investigating relapse-free survival (RFS) in MRD-negative patients, as well as OS and RFS in patients with MRD-positive disease. The study also assessed side effects from Blincyto, as well as the outcomes of patients who went on to receive an allogeneic blood or bone marrow transplant after being treated with the agent.
According to the study’s listing on ClinicalTrials.gov, the final participant in the study was examined or received the drug. Final data will be collected in December 2024.
If approved, Blincyto will be the first FDA-approved bispecific T-cell engager (BiTE) treatment for this specific patient population. BiTE therapy is a type of drug that works by targeting molecules found on cancer cells, as well as T cells, which are part of the immune system. The goal of BiTE therapy is to help T cells find and fight cancer cells, according to the National Cancer Institute. This treatment modality is currently utilized in other blood cancers, such as multiple myeloma.
In June 2023, the FDA approved Blincyto for the treatment of patients with B-ALL who are MRD-positive, meaning that they have 0.1% or more MRD. This approval was based on phase 2 study findings that showed that approximately 80% of patients treated with the BiTE therapy had an MRD response, indicating that residual disease was not able to be detected after therapy.
Now, according to Amgen, the FDA plans to make its decision on this indication’s potential approval by June 21, 2024.
Other studies are also investigating the use of Blincyto, such as the phase 3 Golden Gate trial, which is alternating Blincyto with low-intensity chemotherapy in older adults with newly diagnosed Philadelphia chromosome-negative B-ALL, which is currently enrolling patients.
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