FDA Adds CLL/SLL to Brukinsa’s Label

The FDA recently gave an additional approval to BeiGene, Ltd.’s Brukinsa (zanubrutinib), which is already approved for three other rare types of non-Hodgkin lymphoma. Respondents to a Zitter Insights survey said that while its availability will result in a lower level of unmet need in the treatment of chronic lymphocytic leukemia (CLL), there is still moderate or high unmet need for the condition.

On Jan. 19, the FDA expanded the label of Brukinsa to include the treatment of adults with CLL or small lymphocytic lymphoma (SLL). CLL and SLL are the same disease, a type of non-Hodgkin lymphoma, except CLL cancer cells are mostly in the blood and bone marrow, while in SLL, the cells are mainly in the lymph nodes.

The agency granted the application orphan drug designation, and its review used the Assessment Aid. The recommended dose of the Bruton’s tyrosine kinase (BTK) inhibitor is 160 mg twice daily or 320 mg once daily. Drugs.com lists the price of 120 80 mg capsules as more than $15,264.

The newest approval is based on two international Phase III clinical trials. In the SEQUOIA trial, Brukinsa demonstrated better progression-free survival than the comparator bendamustine/rituximab arm, 85.5% vs. 69.5%, in the first-line setting. And in the ALPINE trial, Brukinsa had an 80.4% overall response rate compared with ibrutinib’s 72.9%. The trials’ overall safety profiles were consistent with those of previous studies.

The drug also has approvals in mantle cell lymphoma, Waldenström’s macroglobulinemia and marginal zone lymphoma. The FDA first approved it on Nov. 14, 2019.

“With four US approvals in just over three years and demonstrated superiority versus ibrutinib in the final progression-free survival (PFS) analysis of the ALPINE trial, we believe BRUKINSA is well-positioned to become the BTKi of choice across multiple indications,” said Mehrdad Mobasher, M.D., M.P.H., chief medical officer of hematology at BeiGene, in a statement.

For the Managed Care Oncology Index: Q2 2022, from June 9, 2022, to July 12, 2022, Zitter Insights polled 34 commercial payers covering 110.4 million lives, 28 Medicare payers representing 39.3 million lives and 100 oncologists about Brukinsa. Payers covering almost 80% of commercial lives said they were at least somewhat aware of the agent, while those representing more than 90% of Medicare lives ranked their awareness level similarly. More than two-thirds of oncologists reported the same.

Both AIS Health and Zitter Insights are divisions of MMIT.

Once Brukinsa is available for CLL, the average perceived unmet need in CLL will drop, said respondents, although most said that there will still be moderate or high unmet need (see chart).

With Brukinsa’s availability, 57% of the surveyed oncologists ranked the disease burden for people with CLL as average compared with payers covering 45% of commercial lives and ones with 53% of Medicare lives.

Commercial payers with 51% of covered lives and Medicare payers representing 45% of beneficiaries said they expect Brukinsa to have a moderate impact on the CLL class, meaning that there will not be a change in coverage, but there will be a change in tiering and/or utilization management criteria for some products. Forty-three percent of oncologists said it will have a moderate impact on new patients, meaning that they expect their treatment approach to change for a considerable portion of those patients, compared with 37% who said the same about current patients.


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

© 2024 MMIT
Angela Maas

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.

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