By Padmanabhan Ananthan and Christy Santhosh (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. Verastem said the combination treatment, branded as Avmapki Fakzynja Co-pack, will be available in one week at a […]
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US FDA approves Verastem’s ovarian cancer therapy
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By Padmanabhan Ananthan and Christy Santhosh
(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.
Verastem said the combination treatment, branded as Avmapki Fakzynja Co-pack, will be available in one week at a list price of $48,500 for a 28-day prescription.
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, Verastem said, adding that the U.S. approval leads to an initial opportunity of reaching up to 1800 patients.
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.
“Physician feedback suggests strong adoption enthusiasm” for the drug, according to Jefferies analysts who see a U.S. opportunity worth $402 million for the treatment.
The combination drug works by inhibiting multiple pathways that promote cancer cell survival and growth.
Shares of the Massachusetts-based company climbed 5% in afternoon trading.
(Reporting by Sriparna Roy, Padmanabhan Ananthan and Christy Santhosh in Bengaluru; Editing by Leroy Leo)