The FDA has granted accelerated approval to zanubrutinib, a small molecule BTK inhibitor, for the treatment of adults with relapsed or refractory marginal zone lymphoma who have received at least one anti-CD20-based regimen, according to a press release from the manufacturer.
The approval is based on results from two single-arm clinical trials evaluating the overall response rate of the treatment as the primary endpoint. The release noted that patients enrolled in the MAGNOLIA trial had an ORR of 56% (95% CI: 43-68) and a complete response rate of 20%. The ORR based on an assessment prioritizing PET-CT scan was 67% (95% CI, 57-48) with a CR rate of 26%.
After a median follow-up of 8.3 months, the median duration of response was not reached, with 85% of patients still in remission at 12 months (95% CI, 67-93).
In the phase 1/2 BGB-311-AU-003 trial, the ORR was 80% (95% CI, 56-94) with a CR rate of 20%. The median duration of response was also not reached in this trial, with 72% of responders still in remission at 12 months (95% CI, 40-88).
“BTK plays a critical role in B-cell receptor signaling, a driver in the development of marginal zone lymphoma. In the MAGNOLIA trial, [zanubrutinib] demonstrated impressive overall response and complete remission rates, with responses observed in all MZL subtypes,” Stephen Opat, FRACP, FRCPA, MBBS, lead MAGNOLIA investigator of Monash University, said in the release. “We are optimistic that [zanubrutinib] will bring clinically meaningful benefit to patients with relapsed or refractory marginal zone lymphoma.”
The most common adverse reactions in the two studies included decreased neutrophil count, upper respiratory tract infection, and decreased platelet count.
According to the release, zanubrutinib is being evaluated as a monotherapy and in combination with other drugs to treat B-cell malignancies. The FDA has also approved the medication to treat mantle cell lymphoma in adults who have received at least one prior therapy and for adults with Waldenström’s macroglobulinemia. In addition, the release noted more than 30 applications are pending with the FDA and other regulatory agencies for new indications for the medication.
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