Nintedanib granted orphan drug designation for treatment of mesothelioma.
Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to nintedanib for the treatment of mesothelioma. Orphan drug designation is granted by the FDA to investigational compounds intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people.
Mesothelioma is a rare cancer that affects the lining or membrane (the mesothelium) that covers and protects organs in the body. Mesothelioma occurs most frequently in the cells lining the lungs, this is known as malignant pleural mesothelioma (MPM).
“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,” said Martina Flammer, M.D., vice president, clinical development and medical affairs specialty care, Boehringer Ingelheim. “We are proud to receive this designation for nintedanib from the FDA, resulting from our ongoing commitment to researching potential treatment options for rare cancers such as mesothelioma.”
Nintedanib was granted orphan drug designation based in part on data from the Phase II cohort of the ongoing Phase II/III LUME-Meso trial. LUME-Meso is an international, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety profile of nintedanib plus chemotherapy (pemetrexed/cisplatin) followed by nintedanib monotherapy, versus placebo plus chemotherapy (pemetrexed/cisplatin) followed by placebo monotherapy, in patients with histologically confirmed, unresectable MPM.
Clinically meaningful results from the LUME-Meso Phase II trial in patients with unresectable MPM were presented in an oral session at the 17th IASLC World Conference on Lung Cancer in Vienna on December 7.
The Phase III LUME-Meso trial (NCT01907100) is currently recruiting patients worldwide. The Phase III portion of the trial plans to randomize 450 patients at 137 sites in 27 countries.
(Source: PR Newswire)