By Mike Harris Thursday, July 6th, 2023

Correction: The headline on this article has been updated.

The U.S. Food and Drug Administration has approved Amgen’s supplemental biologics license for Blincyto, which treats adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia, the Thousand Oaks-based life sciences giant announced on June 20.

The patients have the leukemia in first or second complete remission with minimal residual disease greater than or equal to 0.1%, based on additional data from two Phase 3 studies that were submitted, Amgen said in a press release.

The approval converts Blincyto’s accelerated approval to full approval, the release said.

“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,” David Reese, M.D., executive vice president of Research and Development at Amgen, said in the release.

BiTE means bispecific T-cell engager. MRD is minimal residual disease.

Reese said the approval underscores the clinical benefit of Blincyto for people living with B-ALL.

B-ALL stands for B-cell acute lymphoblastic leukemia.

“And we look forward to exploring how we can continue to make a significant impact for these patients,” Reese said.

Blincyto has been shown to “allow for the extension of life expectancy in this population which essentially has dire circumstances,” Sumita Bhatta, an oncologist and vice president of medical affairs for oncology at Amgen, told the Business Times.

Bhatta said that an earlier treatment study showed that patients who received Blincyto in the consolidation portion of their treatment had improved survival over those who received standard-care chemotherapy in the consolidation portion.

Amgen is excited about the FDA’s full approval of Blincyto “because it validates the robustness of the clinical data that the drug got initial approval on in 2018,” she said.

Principal investigator Elias Jabbour, M.D., said in the release that in a Phase 2 study, roughly 80% of adult patients treated with Blincyto, also known as blinatumomab, experienced a complete minimal residual disease response.

Jabbour is with the Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston.

“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 acute lymphoblastic leukemia with minimal residual disease present following a remission, which is a strong predictor of relapse in this patient population, Jabbour said.

Blincyto is a BiTE immuno-oncology therapy that targets CD19 surface antigens on B cells, according to the release.

BiTE molecules fight cancer by helping the body’s immune system detect and target malignant cells by engaging T cells to cancer cells, the release says.

T cells are a type of white blood cell capable of killing other cells perceived as threats.

By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death.

Amgen continues to advance a robust development program for Blincyto, the release says.

“We hope that we can minimize chemotherapy use with this drug,” Bhatta said. “And that’s what we’re continuing to move forward with.”

The development program includes trials designed to lessen chemotherapy, studies aimed at treating patients with minimal residual disease-negative B-ALL, and the clinical investigation of a subcutaneous formulation, all intended to help address remaining unmet needs for patients, according to the release.

BiTE immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers, the release says.

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