Blinatumomab Now Fully Approved by FDA for MRD+ B-ALL

• Blinatumomab (Blincyto) was first granted breakthrough therapy and priority review deisgnations by the FDA.
• Blinatumomab is indicated in the United States for the treatment of both B-cell precursor acute lymphoblastic leukemia (B-ALL) and relapsed or refractory CD19-positive B-cell precursor ALL in adults and pediatric patients.
• In Europe, blinatumomab has 3 indications in ALL populations.

The FDA awarded full approval to blinatumomab for the treatment of adults and pediatric patients with CD19-positive B-ALL who had first or second complete remission with minimal residual disease (MRD) of at least 0.1%.¹

"In a phase 2 study, roughly 80% of adult patients treated with blinatumomab experienced a complete MRD response," said principal investigator Elias Jabbour, MD, professor, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston, in a press release. "The FDA's decision to grant a full approval for blinatumomab further validates the use of this therapy to treat adults and children with B-cell precursor ALL with MRD present following a remission, which is a strong predictor of relapse in this patient population."

As previously reported by Targeted Oncology™ in 2018, approval was originally granted based on results from the single-arm BLAST trial (NCT01207388) following an affirmative 8 to 4 vote from the FDA Oncologic Drugs Advisory Committee (ODAC). The majority of patients treated with blinatumomab in BLAST achieved a complete MRD response, leading to a significant improvement in relapse-free survival and overall survival, according to published findings.² Conversion to a full approval results from 2 phase 3 studies, which provided additional data.¹

"We are pleased the FDA has granted full approval for Blincyto, the first FDA-approved CD19-directed CD3 T-cell engager BiTE® immunotherapy and the first to be FDA-approved for MRD in 2018," said David M. Reese, MD, executive vice president of Research and Development at Amgen, in the press release. "Today's full approval underscores the clinical benefit of Blincyto for people living with B-ALL, and we look forward to exploring how we can continue to make a significant impact for these patients."

_REFERENCES:

_{1. FDA grants full approval for Blincyto® (Blinatumomab) to treat minimal residual disease-positive b-cell precursor acute lymphoblastic leukemia. News release. June 21, 2023. Accessed June 21, 2023. https://tinyurl.com/2bamekp2}

_{2. Gokbiget N, Dombret H, Bonifacio M, et al. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018;131(14):1522-1531. doi: 10.1182/blood-2017-08-798322.}