US FDA grants expanded approval for BeiGene's blood cancer drug

US FDA nod: The US Food and Drug Administration (FDA) has granted accelerated approval for the expanded use of BeiGene's combination drug to treat certain patients with a type of blood cancer, the health regulator announced on Thursday.

The oral drug, Brukinsa, in combination with Roche's Gazyva, has been approved to treat relapsed or refractory follicular lymphoma in patients who have undergone at least two prior lines of treatment.

According to BeiGene, the US wholesale acquisition cost for Brukinsa stands at $15,066 for a 30-day supply, with consistent pricing across all indicated uses.

Follicular lymphoma, a type of cancer that originates in the white blood cells, sees approximately six new cases reported per 100,000 people annually in the US, according to government data.

Belonging to the same drug class as AbbVie's Imbruvica, Brukinsa targets Bruton's tyrosine kinase (BTK) protein to inhibit the proliferation of malignant B-cells. Other treatment options for patients with relapsed or refractory follicular lymphoma include cell therapies like Novartis' Kymriah and Gilead Sciences' Yescarta.

The approval of Brukinsa was based on data from a mid-stage study, demonstrating the drug's effectiveness in combination with Gazyva in reducing cancerous tumours compared to Gazyva alone.

Brukinsa is already approved in the United States to treat four other types of blood cancers and achieved global sales of $1.3 billion last year. BeiGene has confirmed that a confirmatory late-stage study is underway to secure full US approval.

Analysts estimate Brukinsa's peak annual sales to range between $3 billion to $4 billion.

(With Reuters Innputs)