Article Type
Changed
Fri, 03/08/2024 - 14:42

The US Food and Drug Administration has granted accelerated approval to the Bruton’s kinase inhibitor zanubrutinib (Brukinsa, BeiGene USA) with obinutuzumab (Gazyva, Roche) for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

Approval was based on the ROSEWOOD trial, which included 217 adults with relapsed or refractory follicular lymphoma randomized 2:1 to obinutuzumab plus zanubrutinib 160 mg orally twice daily until disease progression or unacceptable toxicity or to obinutuzumab alone. Participants had a median of three prior lines of treatment and as many as 11. 

The overall response rate was 69% with zanubrutinib add-on vs 46% with stand-alone obinutuzumab (= .0012). After a median follow-up of 19 months, the median duration of response was 14 months with obinutuzumab alone but not reached in the combination arm and estimated to be 69% at 18 months.

Across clinical trials, the most common adverse events with zanubrutinib were decreased neutrophil counts (51%), decreased platelet counts (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Serious adverse reactions occurred in 35% of patients.

The recommended zanubrutinib dose is 160 mg taken orally twice daily or 320 mg taken orally once daily until disease progression or unacceptable toxicity.

Previously approved indications for the kinase inhibitor include mantle cell lymphoma, Waldenström’s macroglobulinemia, chronic lymphocytic leukemia, and small lymphocytic lymphoma.

According to drugs.com, 120 80-mg capsules cost $15,874.

A version of this article appeared on Medscape.com .

Publications
Topics
Sections

The US Food and Drug Administration has granted accelerated approval to the Bruton’s kinase inhibitor zanubrutinib (Brukinsa, BeiGene USA) with obinutuzumab (Gazyva, Roche) for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

Approval was based on the ROSEWOOD trial, which included 217 adults with relapsed or refractory follicular lymphoma randomized 2:1 to obinutuzumab plus zanubrutinib 160 mg orally twice daily until disease progression or unacceptable toxicity or to obinutuzumab alone. Participants had a median of three prior lines of treatment and as many as 11. 

The overall response rate was 69% with zanubrutinib add-on vs 46% with stand-alone obinutuzumab (= .0012). After a median follow-up of 19 months, the median duration of response was 14 months with obinutuzumab alone but not reached in the combination arm and estimated to be 69% at 18 months.

Across clinical trials, the most common adverse events with zanubrutinib were decreased neutrophil counts (51%), decreased platelet counts (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Serious adverse reactions occurred in 35% of patients.

The recommended zanubrutinib dose is 160 mg taken orally twice daily or 320 mg taken orally once daily until disease progression or unacceptable toxicity.

Previously approved indications for the kinase inhibitor include mantle cell lymphoma, Waldenström’s macroglobulinemia, chronic lymphocytic leukemia, and small lymphocytic lymphoma.

According to drugs.com, 120 80-mg capsules cost $15,874.

A version of this article appeared on Medscape.com .

The US Food and Drug Administration has granted accelerated approval to the Bruton’s kinase inhibitor zanubrutinib (Brukinsa, BeiGene USA) with obinutuzumab (Gazyva, Roche) for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

Approval was based on the ROSEWOOD trial, which included 217 adults with relapsed or refractory follicular lymphoma randomized 2:1 to obinutuzumab plus zanubrutinib 160 mg orally twice daily until disease progression or unacceptable toxicity or to obinutuzumab alone. Participants had a median of three prior lines of treatment and as many as 11. 

The overall response rate was 69% with zanubrutinib add-on vs 46% with stand-alone obinutuzumab (= .0012). After a median follow-up of 19 months, the median duration of response was 14 months with obinutuzumab alone but not reached in the combination arm and estimated to be 69% at 18 months.

Across clinical trials, the most common adverse events with zanubrutinib were decreased neutrophil counts (51%), decreased platelet counts (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Serious adverse reactions occurred in 35% of patients.

The recommended zanubrutinib dose is 160 mg taken orally twice daily or 320 mg taken orally once daily until disease progression or unacceptable toxicity.

Previously approved indications for the kinase inhibitor include mantle cell lymphoma, Waldenström’s macroglobulinemia, chronic lymphocytic leukemia, and small lymphocytic lymphoma.

According to drugs.com, 120 80-mg capsules cost $15,874.

A version of this article appeared on Medscape.com .

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article