SWITZERLAND— The FDA has approved BeiGene’s Brukinsa (zanubrutinib), an expedited therapy for BTK inhibitor-resistant follicular lymphoma, in conjunction with Genentech’s Gazyva (obinutuzumab) to treat patients who have had at least two lines of systemic therapy but are relapsed or resisting treatment.

According to BeiGene’s release, Brukinsa is now the first and only BTK inhibitor approved for treatment in follicular lymphoma (FL) and the first medication in this class to secure five cancer indications due to the regulatory victory.

The approval on Thursday, according to BeiGene CMO Mehrdad Mobasher, is a “testament to Brukinsa’s differentiate clinical profile” and notes that the drug “is the only BTK inhibitor to date that shows efficacy with this type of malignancy and now has the broadest label.”

The FDA’s decision was supported by data from the Phase II ROSEWOOD trial, an open-label, randomized research study that showed a 69% overall response rate (ORR) in patients receiving both Gazyva and Brukinsa.

The ORR for those who received Gazyva by itself was 46%. BeiGene reported a p-value of 0.0012, indicating that the treatment difference was statistically significant in favour of Brukinsa.

ROSEWOOD reported a “landmark” length of response rate in the combination treatment arm at 18 months, which was 69%.

Regarding safety, the study revealed that Brukinsa in combination with Gazyva was generally well tolerated, exhibiting a safety profile in line with the previously published guidelines for both medications.

Of the patients on the combined regimen, 17% stopped taking Brukinsa permanently due to toxicities, and 35% experienced significant side effects.

The FDA’s fast process allowed Brukinsa’s FL approval; nevertheless, BeiGene must conduct a confirmatory trial to substantiate Brukinsa’s therapeutic advantages in this indication. The Phase III MAHOGANY experiment is presently being conducted by the biotech.

Brukinsa is a small molecule inhibitor of the protein Bruton’s tyrosine kinase, which is implicated in signaling pathways leading to the proliferation, adhesion, and motility of B cells. Because of its mode of action, Brukinsa can suppress and impede the formation of tumors as well as the proliferation of malignant B-cells.

For the treatment of mantle cell lymphoma in adult patients who had received at least one prior line of therapy, the medication was originally licensed in November 2019.

Brukinsa has since discovered additional indications, such as Waldenström’s macroglobulinemia, a blood cell malignancy, chronic lymphocytic lymphoma, and marginal zone lymphoma that has relapsed or is refractory.

With the withdrawal of two accelerated approvals for Imbruvica (ibrutinib), one of Brukinsa’s main rivals, by AbbVie and J&J almost a year ago, BeiGene remains the only approved BTK inhibitor.

The pharma partners discontinued Imbruvica’s designations for marginal zone lymphoma and mantle cell lymphoma due to unsatisfactory results from Phase III confirmatory trials.

Seventy markets, including the United States, the European Union, Great Britain, Canada, Australia, China, South Korea, and Switzerland, have approved BRUKINSA for specific indications. More indications are being developed globally.

Over 5,000 participants have been engaged in the global BRUKINSA development program from 29 different nations and regions so far.

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