US FDA Nods expanded use of BeiGene's Blood Cancer Drug

The U.S. Food and medication Administration has granted fast approval for BeiGene's combo medication to treat some patients with a kind of blood cancer, the health authority announced.

The oral medication Brukinsa, in combination with Roche's Gazyva, has been approved to treat relapsed or refractory follicular lymphoma in patients who have had at least two previous lines of treatment. The U.S. wholesale purchase cost for Brukinsa is $15,066 for a 30-day supply, according to the manufacturer, and the drug is priced similarly for all indicated uses.

Follicular lymphoma is a type of malignancy that originates in white blood cells. According to government data, approximately six new cases of the cancer are reported per 100,000 persons in the United States each year.

Brukinsa is in the same class of medications as AbbVie's Imbruvica, which targets a protein called Bruton's tyrosine kinase (BTK) and inhibits the growth of malignant B cells. Other therapeutic options for patients with recurrent or refractory follicular lymphoma include cell treatments like Novartis' Kymriah and Gilead Sciences' Yescarta.

Brukinsa's approval was based on findings from a mid-stage research in which the medicine in combination with Gazyva helped eradicate or greatly reduce malignant tumors in patients when compared to Gazyva alone. It is approved in the United States to treat four different forms of blood cancer and had global sales of $1.3 billion last year. BeiGene stated that a confirmatory late-stage trial was under underway, which was required to obtain full US approval.