Newton Pharmaceutical Company Gets FDA Approval For Cancer Drug

NEWTON, MA — A Newton-based pharmaceutical research company received U.S. Food and Drug Administration approval on Dec. 18 to use its new drug to treat one of the most prevalent types of blood cancer.

The FDA approved the use of Karyopharm Therapeutics' drug called XPOVIO, or selinexor, as a treatment for patients with multiple myeloma, the company announced.

Selinexor is a drug used to treat adults with certain types of diffuse large B-cell lymphoma that has come back or has not gotten better after treatment with at least two types of systemic therapy.

XPOVIO was previously approved under the FDA's Accelerated Approval Program for the treatment of adults with relapsed or refractory multiple myeloma who had received at least four prior therapies and whose disease met other specifics. It's now been approved for the treatment of adults with multiple myeloma who have received at least one prior therapy.

Founder and Chief Scientific Officer of Karyopharm Sharon Shacham said this is great news.

"We believe the expanded reach of XPOVIO will address a critical need for patients with multiple myeloma given its novel mechanism of action, convenient oral administration and established rapid and sustained efficacy profile," she said in a statement.

The XPOVIO label expansion approval was supported by a Phase 3 BOSTON study, which was recently published in medical journal The Lancet.

According to the National Cancer Institute, multiple myeloma is one of the most common types of blood cancer in the U.S. with more than 140,000 people living with the disease and more than 32,000 new cases each year. It is most frequently diagnosed among people between 65-74 years old. Despite recent therapeutic advances, there is no cure. According to the institute, some 13,000 people die annually because of complications with multiple myeloma.

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