FDA Approves Treatment for Rare Form of Acute Lymphoblastic Leukemia


The FDA today approved blinatumomab for the treatment of Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia, a rare form of ALL.

The FDA today approved blinatumomab (Blincyto) for the treatment of Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), a rare form of ALL.

Blincyto is the first approved drug that engages the body’s T-cells to destroy leukemia cells, according to a FDA press release.

The drug acts as a connector between a protein called CD19, which is found on the surface of most B-cell lymphoblasts, and CD3, a protein on T-cell lymphocytes, according to the FDA.

The immunotherapy is intended for patients whose cancer has returned after treatment or for patients who did not previously respond to treatment, the FDA stated.

A study suggested Blincyto showed a “substantial improvement” over available therapies in terms of treatment. The study involved 185 adults with Philadelphia chromosome-negative relapsed or refractory precursor B-cell ALL, and after at least 4 weeks of infusion, 32% of patients experienced complete remission for over 6 months.

“Immunotherapies, especially Blincyto with its unique mechanism of action, are particularly promising for patients with leukemia,” said Richard Pazdur, MD, director of the office of hematology and oncology products in the FDA’s center for drug evaluation and research, in a press release. “Recognizing the potential of this novel therapy, the FDA worked proactively with the sponsor under our breakthrough therapy designation program to facilitate the approval of this novel agent.”

By the end of the year, more than 6000 Americans will be diagnosed with the uncommon form of ALL, according to the National Cancer Institute.

Related Videos
Laboratory test tubes and solution with stethoscope background | Image Credit: Shutter2U - stock.adobe.com
Image credit: Andrea Izzotti
Inflation Reduction Act is shown using the text and the US flag - Image credit: Andrii | stock.adobe.com
Pharmacy Interior | Image Credit: Tyler Olson - stock.adobe.com
Male pharmacist selling medications at drugstore to a senior woman customer | Image Credit: Zamrznuti tonovi - stock.adobe.com
Pharmacist assists senior woman in buying medicine in pharmacy - Image credit: Drazen | stock.adobe.com
Pharmacy, medicine and senior woman consulting pharmacist on prescription. Healthcare, shopping and elderly female in consultation with medical worker for medication box, pills or product in store - Image credit: C Daniels/peopleimages.com | stock.adobe.com
Image credit: fidaolga - stock.adobe.com
Pharmacists checking inventory at hospital pharmacy- Image credit: Jacob Lund | stock.adobe.com
Young male pharmacist giving prescription medications to senior female customer in a pharmacy | Image Credit: Zamrznuti tonovi - stock.adobe.com
© 2023 MJH Life Sciences

All rights reserved.