The FDA on Friday gave its stamp of approval to Amgen’s Blincyto to treat both adults and children with the most common type of acute lymphoblastic leukemia, marking the third indication for the drug.
The approval is based on positive results from the NIH-funded Phase 3 E1910 clinical trial, which evaluated overall survival in patients 1 month and older with the blood cancer known as CD19-positive Philadelphia chromosome-negative B cell precursor acute lymphoblastic leukemia, or B-ALL, in the consolidation phase of multi-phase chemo.
The study found that Blincyto was effective at improving overall survival compared to chemotherapy alone. The 5‑year OS was 78.4% in the Blincyto arm versus 41.4% in the chemotherapy arm, according to the FDA.
Jay Bradner“Today’s approval in the frontline consolidation phase, regardless of measurable residual disease status, allows us to reach more patients than ever with this transformative, first-in-class Bispecific T-cell Engager (BiTE) therapy,” Amgen R&D chief and CSO Jay Bradner said in a statement.
In 2023, Blincyto sales totaled $861 million, or 48% more than in 2022. Last June, Blincyto converted its accelerated approval to a full approval for the treatment of adults and pediatric patients with CD19-positive B-ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
Anders Kolb, president and CEO of the Leukemia & Lymphoma Society, said in a statement that the risk of recurrence after the initial phase of treatment is relatively high and patients need a treatment option early on.
“B-ALL is the most common type of ALL and having another effective option available earlier in a patient’s treatment journey is critical for clinicians who are working to give these patients more time with their loved ones,” he said.
The study was sponsored by ECOG-ACRIN Cancer Research Group with funding from the NIH’s National Cancer Institute.