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FDA Approves 1st Tx for Rare Non-Cancerous Tumors – Ogsiveo

……..catching up on FDA approvals

The FDA approved a new ORAL therapy, Ogsiveo (nirogacestat) to SpringWorks Therapeutics Inc., for adult patients with progressing desmoid tumors who require systemic treatment.  Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas. 

Desmoid tumors are diagnosed in about 3 to 5 people per million a year. Previous treatments included surgery, chemotherapy, radiation and tyrosine kinase inhibitors, Unfortunately, recurrence rates have remained high. The tumors commonly invade into surrounding structures and organs, resulting in pain, issues with being able to move, and decreased quality of life.

SpringWorks announced that Ogsiveo will be sold in the U.S. at a list price of $29,000 for a 30-day supply.  Since launch the company also announced that Ogsiveo would be available through select specialty distributors or through its limited specialty pharmacy network which includes Onco360 and Biologics by McKesson.

CLICK HERE for prescribing information

CLICK HERE for the FDA press release

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