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By Mariam Sunny and Sneha SK
March 7 (Reuters) – The U. S. Food and Drug Administration has granted accelerated approval for the expanded use of BeiGene’s combination drug to treat certain patients with a type of blood cancer, the fitness regulator said on Thursday.
The oral drug Brukinsa, in blend with Roche’s Gazyva, has been used to treat relapsed or refractory follicular lymphoma in patients who have gained at least two prior lines of therapy.
Brukinsa’s wholesale purchase price in the U. S. It’s $15,066 for a 30-day supply, the company said, adding that the drug’s value is for all stated uses.
Follicular lymphoma is a type of cancer that begins in white blood cells. In the U. S. , about six new cases of cancer are reported per 100,000 people each year, according to government data.
Brukinsa belongs to the same class of drugs as AbbVie’s Imbruvica, which targets a protein called Bruton’s tyrosine kinase (BTK) and inhibits the proliferation of malignant B cells.
Other remedy features for patients with relapsed or refractory follicular lymphoma come with mobile treatments such as Kymriah from Novartis and Yescarta from Gilead Sciences.
Brukinsa’s approval was based on data from an interim study in which combining the drug with Gazyva helped specifically destroy or shrink cancerous tumors in patients, compared to Gazyva alone.
Brukinsa is approved in the U. S. It was used to treat four other types of blood cancer and generated $1. 3 billion in global sales last year.
BeiGene said a final stage of confirmation is underway, which is necessary to get full U. S. approval.
Yaron Werber, an analyst at TD Cowen, estimates Brukinsa’s peak annual sales to be between $3 billion and $4 billion. (Reporting by Sriparna Roy, Sneha SK and Mariam Sunny in Bengaluru; editing by Leslie Adler and Shounak Dasgupta)