FDA Grants Orphan Drug Designation to Nintedanib for Mesothelioma
Boehringer Ingelheim has announced that the FDA has granted orphan drug designation to nintedanib, a triple angiokinase inhibitor, for the treatment of mesothelioma.
The company revealed results from its LUME-Meso phase 2 trial at the beginning of December, which showed how nintedanib (with pemetrexed/cisplatin) could affect patients with unresectable malignant pleural mesothelioma (MPM). The researchers concluded that nintedanib, in combination with pemetrexed/cisplatin, demonstrated a significant clinical benefit compared to a placebo.
The most common adverse effects associated with nintedanib were neutropenia, elevated liver enzymes, and an increase in gamma glutamyltransferase.
"Nintedanib, our triple angiokinase inhibitor, has shown promise as a potential treatment for malignant pleural mesothelioma in clinical trials to-date, and this designation is a validating milestone in its development," Martina Flammer, MD, Vice President of Clinical Development & Medical Affairs Specialty Care at Boehringer Ingelheim, said in a press release. "
The company is now recruiting participants for its next study on nintedanib. The phase 2/3 trial will evaluate the safety and efficacy of nintedanib in combination with pemetrexed/cisplatin, and nintedanib with pemetrexed/cisplatin, followed by a placebo.