FDA Grants Orphan Drug Designation to Novel Mesothelioma Treatment

The U.S. Food and Drug Administration has granted orphan drug designation to ONCOFID-P for the treatment of malignant pleural mesothelioma, a step toward another potential therapy option for patients.

ONCOFID-P is an innovative drug conjugate already in advanced clinical development for the treatment of invasive bladder cancer. The mesothelioma designation is based on preclinical data showing high antitumor activity in laboratory and mice models.

Fidia Farmaceutici, a multinational research company based in Italy, announced the latest FDA designation, which is designed to encourage the development of novel drugs, particularly for rare diseases, and help facilitate the approval process.

“I’m quite excited about where we are at, and where this is going,” University of Padua Professor Antonio Rosato, who has led the drug’s development, told The Mesothelioma Center at Asbestos.com. “This represents an important step forward for treatment.”

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