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FDA Approves BiTE Therapy for Adults and Children with Leukemia Subtype

Blinatumomab has received full approval from the FDA after long-term data confirmed its safety and efficacy.

Rye Brook, N.Y., July 7, 2023 – The U.S. Food and Drug Administration (FDA) this month awarded full approval to blinatumomab (Blincyto®) for use in adults and children with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) whose disease is in its first or second complete remission and have a small number of cancer cells left after treatment.

Blinatumomab was approved by FDA in 2018 under an “accelerated pathway,” which provides earlier access to treatments for rare diseases. The latest decision by FDA is based on larger and longer-term studies confirming the drug’s safety and efficacy. Blinatumomab was the first of now five bispecific antibodies approved to treat blood cancers.

“Bispecific antibodies are a revolution in blood cancer treatment,” said Lee Greenberger, PhD, Chief Scientific Officer at The Leukemia & Lymphoma Society (LLS). “As their name implies, these next-generation immunotherapies work by zeroing in on two targets in the body—cancer cells and the immune T-cells that can kill them.”

Data that were used in the decision to approve blinatumomab showed that most adults who received the drug experienced a complete minimal residual disease response. Healthcare providers test for minimal residual disease, which is the number of cancer cells remaining in the body after treatment. Doctors may order additional treatment if a certain number of cancer cells are found.

Some of the latest research has focused heavily on harnessing the power of a patient’s own immune system, and LLS has been from the outset, and continues to be, committed to being a part of this innovation.

“At LLS, we are constantly looking for ways to innovate and create new ways to better treat patients,” Dr. Greenberger said. “We’re also investigating why some cancers respond to treatment, while others do not. Recently we awarded a grant to study blinatumomab resistance and responses in children with relapsed B-ALL.”

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