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FDA Grants Full Approval for Blincyto in Certain People With ALL

July 20

The FDA recently converted accelerated approval to full for Amgen Inc.’s Blincyto (blinatumomab) for certain patients with acute lymphoblastic leukemia (ALL). While the drug is one of many others approved for the condition, respondents to a Zitter Insights survey said there is still unmet need in treating the disease.

On June 21, 2023, the FDA granted full approval to Blincyto for the treatment of adults and pediatric patients with CD19-positive B-cell precursor ALL — which is also known as acute lymphocytic leukemia — in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. The agency first approved the CD19-directed CD3 T-cell engager on Dec. 3, 2014; the accelerated approval for MRD-positive B-cell ALL was granted on March 29, 2018.

Dosing consists of 28 days of continuous intravenous infusion via an infusion pump and then a 14-day treatment-free interval. For a treatment course of four cycles, people weighing at least 45 kg are administered 28 mcg/day for the first 28 days of each cycle. People weighing less than 45 kg are given 15 mcg/m²/day on the same schedule. Drugs.com lists the price of one 35 mcg lyophilized powder in a single-dose vial as more than $5,169.

In Amgen’s press release on the most recent approval, David M. Reese, M.D., executive vice president of research and development for the manufacturer, notes that Blincyto is the first CD19-directed CD3 T-cell engager BiTE — or Bispecific T cell Engager — immunotherapy that the FDA has approved and the first approved for MRD.

“In a Phase 2 study, roughly 80% of adult patients treated with blinatumomab experienced a complete MRD response,” said principal investigator Elias Jabbour, M.D., department of leukemia within the 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 ALL with MRD present following a remission, which is a strong predictor of relapse in this patient population.”

For the Managed Care Oncology Index: Q2 2022, from June 9, 2022, to July 12, 2022, Zitter Insights polled 35 commercial payers covering 119.9 million lives, 28 Medicare payers representing 39.3 million lives and 100 oncologists about their management and prescribing of ALL therapies. Out of 11 agents in the class, Blincyto was used on the largest number of unique patients — 47% — in the year prior to the survey.

Payers covering 62% of commercial lives and 58% of Medicare lives said that managing branded treatments for ALL is an average priority. Those representing almost 90% of commercial beneficiaries and 95% of Medicare lives reported that they are slightly or somewhat aggressive in their management of branded ALL agents.

Both AIS Health and Zitter Insights are divisions of MMIT.

Commercial payers with 78% of lives and Medicare payers with 67% of lives expressed average satisfaction with the current treatments compared with 44% of oncologists. However, opinions vary on how respondents perceive the unmet need in the treatment of the disease (see chart).

For more information on the Zitter Insights data, contact Jill Brown Kettler at jkettler@mmitnetwork.com.

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Spotlight on Market Access

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.