FDA Conditionally Approves Expanded Use Of BeiGene's Combination Drug For Certain Type Of Blood Cancer

Thursday, the FDA granted accelerated approval to BeiGene Ltd’s BGNE Brukinsa (zanubrutinib) for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), in combination with Roche Holdings AG’s RHHBY Gazyva (obinutuzumab), after two or more lines of systemic therapy. 

The indication is approved under accelerated approval based on response rate and durability of response, marking Brukinsa’s fifth indication in B-cell malignancies in the U.S.

Follicular lymphoma is the most common type of low-grade non-Hodgkin lymphoma (NHL). It develops when white blood cells cluster to form lumps in lymph glands or organs.

Approximately 15,000 cases are diagnosed in the U.S. each year.

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The U.S. wholesale acquisition cost for Brukinsa is $15,066 for a 30-day supply, Reuters noted, adding that the drug is priced similarly for all indicated uses.

Brukinsa belongs to the same class of drugs as AbbVie Inc’s ABBV Imbruvica. Other treatment options for patients with relapsed or refractory follicular lymphoma include cell therapies such as Novartis AG’s NVS Kymriah and Gilead Sciences Inc’s GILD Yescarta.

Brukinsa was approved for R/R FL under the FDA’s accelerated approval program based on the overall response rate (ORR) from the ROSEWOOD Phase 2 trial. 

In the study, the ORR was 69% in the Brukinsa plus obinutuzumab arm versus 46% in the obinutuzumab arm (P=0.0012), with a median follow-up of approximately 20 months. 

Responses were durable, with an 18-month duration of response of 69% in the Brukinsa combination arm.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory MAHOGANY trial, which is underway.

Brukinsa is approved in the United States to treat four other types of blood cancers.

Global sales of Brukinsa of $413.0 million and $1.3 billion for the fourth quarter and full year 2023, respectively, compared to $176.1 million and $564.7 million a year ago.

Citing T.D. Cowen, Reuters notes Brukinsa’s peak annual sales is estimated to be $3 billion to $4 billion.

Price Action: BGNE shares are up 0.94% at $163.78 on the last check Friday.