FDA Approves Blincyto for Adults, Children with Acute Lymphoblastic Leukemia Subtype

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The FDA approved Blincyto for patients aged one month and older with CD19-positive, Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia.

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The FDA approved Blincyto for certain patients with acute lymphoblastic leukemia.

The Food and Drug Administration (FDA) approved Blincyto (blinatumomab) for adults and children aged one month and older with CD19-positive, Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (Ph-negative BCP ALL) in the consolidation phase of multiphase chemotherapy.

"[Blincyto] is a novel immune therapy that is designed specifically to treat B-cell ALL that expresses CD-19. It's important to know that almost all B-cell ALL does express CD-19. So this applies to the majority of patients with this disease,” Dr. Marlise Luskin, a medical oncologist at the Dana-Farber Cancer Institute, said in an interview with CURE®.

Research Behind the Adult Indication

The approval was based off findings from the Study E1910 trial, which included adults with newly diagnosed Ph-negative BCP ALL who were in hematologic complete remission (CR; disappearance of cancer) or CR with incomplete peripheral blood count recovery (CRi) after induction and intensification chemotherapy.

Patients were randomly assigned to one of two groups. Half received consolidation Blincyto alone plus multiple cycles of intensive chemotherapy (112 patients) or intensive chemotherapy alone (112 patients).

The main goal of the trial was overall survival (OS; time from treatment until death of any cause). The three-year OS rate was 84.8% in the Blincyto group and 69% in the chemotherapy-only group. A later analysis with a median follow-up of four-and-a-half years showed that the five-year OS rate was 82.4% and 62.5% in the Blincyto and chemotherapy groups, respectively.

The most common side effects observed in 20% or more of patients treated with Blincyto on Study E1910 were: neutropenia, thrombocytopenia, anemia, leukopenia, headache, infection, nausea, lymphopenia, diarrhea, musculoskeletal pain and tremor.

“ALL in adults, has been a disease that has been historically challenging to treat compared to younger patients, particularly pediatric patients,” Luskin said. “ALL in adults is more likely to be refractory to conventional chemotherapy, and that conventional chemotherapy is more difficult for adults to tolerate.”

Support for Blincyto in Children

The Study 20120215 trial also led to the approval, as it included pediatric and young adult patients with Ph-negative BCP ALL. They were randomly assigned to receive Blincyto or intensive combination chemotherapy.

The main goals of this trial were OS and relapse-free survival (RFS; time patients live without their disease coming back). Five-year OS rates were 78.4% and 41.4% in the Blincyto and chemotherapy groups, respectively. Five-year RFS rates were 61.1% in the Blincyto group and 27.6% in the chemotherapy group.

The most common side effects seen on this trial were fever, nausea, headache, rash, hypogammaglobulinemia (a type of immune system disorder) and anemia.

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