BeiGene Gets Its First Regulatory Nod in Australia for Rare Lymphoma

BeiGene may have only been around for the last decade, but its cancer drugs are already making their mark in the world.

The China-based biotech recently broke into the Australian market with its first regulatory approval for Brukinsa (zanubrutinib) in patients with Waldenström’s Macroglobulinemia (WM), a rare lymphoma. The BTK inhibitor will be given to patients who have received at least one prior therapy or as first-line treatment if chemo-immunotherapy is unsuitable.

Following registration of the drug with the Australia Therapeutic Goods Administration (TGA), patients with WM can enjoy immediate access to Brukinsa through a post-approval pre-reimbursement access program sponsored by the company.

Brukinsa is on a roll lately, bagging over a dozen regulatory approvals across the world in less than two years. 

The Australian approval marks the drug’s second in the Asia-Pacific region, following last week’s nod from Singapore’s Health Sciences Authority to treat adult patients with mantle cell lymphoma who have received at least one prior therapy.

Earlier last month, the FDA handed Brukinsa its third approval for another cancer, marginal zone lymphoma, while the agency OK’ed the drug for WM in August.

Phase 3 Trial Showing Brukinsa’s Efficacy

The Australia approval is based on results from the ASPEN trial. The Phase 3 randomized trial pitted the efficacy of Brukinsa against ibrutinib, a first-generation BTK inhibitor. It enrolled patients with relapsed or refractory WM or patients who have never received treatment for the disease.

Brukinsa was shown to generate a numerically higher, very good partial response (VGPR) (28.4%) compared to ibrutinib (19.2%). However, the primary endpoint of statistical superiority related to deep response (VGPR or better) was not met.

Adverse events do happen, leading to discontinuation or dose reduction. An overall safety profile of Brukinsa, which pooled data from 779 patients with B-cell malignancies treated with the drug, showed that common adverse reactions included reduced levels of white blood cells or platelets, upper respiratory tract infection, and hemorrhage, among others. More serious side effects involved a greater reduction of white blood cells or platelets, pneumonia, and anemia.

Welcome News For WM Patients

“BTK inhibition is an established mode of treatment for patients with WM, and the ASPEN trial showed that Brukinsa is highly effective and has improved tolerability compared to the first-generation BTK inhibitor,” said Professor Con Tam, a principal investigator on the Brukinsa program.

“BeiGene first began clinical trials of Brukinsa in Australia in 2013, and since that time, many Australians have benefitted from treatment as part of ongoing clinical studies. We hope this therapy will offer new hope for people living with WM in Australia.”

News of the approval was welcomed by WMozzies, an Australian non-profit dedicated to providing information and support to the WM community.

“While WM is a slow-growing lymphoma, not all patients fully respond to existing therapies, and many discontinue treatment due to side effects,” commented David Young, the National Team Leader at the WMozzies.

“We are pleased to hear that people living with WM in Australia will have immediate access to this next-generation BTK inhibitor that has demonstrated clinical benefit with potential to improve treatment outcomes,” Young said.

With the Australian approval in hand, BeiGene is gunning for a greenlight from the EU. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has already set the mood in mid-September by recommending Brukinsa for the treatment of adult patients with WM who have received at least one prior therapy or as first-line treatment for those unsuitable for chemo-immunotherapy.

Author

Joy Lin

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