(Reuters) -The U.S. Food and Drug Administration has approved Verastem’s combination therapy for patients with a rare type of ovarian cancer who have received prior treatment, the regulator said on Thursday.
The combination drug, branded as Avmapki Fakzynja Co-pack, will be available in one week, the company said. Pricing details for it were not available.
The FDA decision marks the first and only approval for a drug to treat adults with this form of cancer, called low-grade serous ovarian cancer with a mutation in a gene known as KRAS.
About 6,000-8,000 women in the U.S. and 80,000 worldwide are living with this disease, according to the company.
The cancer disproportionately affects younger women and has poor response rates to chemotherapy.
Approval for the drug was based on data from a mid-stage trial of 57 patients who were treated with at least one prior therapy. In the trial, Verastem’s drug significantly improved patients’ response rate while being generally well tolerated.
Share of the company were halted in mid-day trading.
(Reporting by Sriparna Roy and Padmanabhan Ananthan in Bengaluru; Editing by Leroy Leo)
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