It was recently announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) designated nintedanib, an oral triple angiokinase inhibitor by Boehringer Ingelheim, as a Promising Innovative Medicine (PIM). Nintedanib is not yet available to malignant pleural #mesothelioma patients in the UK, but with this designation, the drug could be available to patients 12-18 months before it gains market authorization.
To reach this decision, the MHRA, the UK’s regulatory agency which acts similarly to the the USA’s Food and Drug Administration (FDA), reviewed available data on nintedanib, which included data from BI’s phase 2 LUME-Meso Trial.
Results yielded statistically significant improvements in progression-free survival in patients who received nintedanib in combination with the chemotherapy compared to those who received chemotherapy alone.
The study included 87 patients with unresectable epithelioid or biphasic malignant pleural mesothelioma who had not received previous systemic chemotherapy. Patients were randomized into two arms of the study. The experimental arm received nintedanib in combination with pemetrexed/cisplatin followed by nintedanib alone until progression or toxicity. The placebo comparator arm received a placebo in combination with pemetrexed/cisplatin followed by a placebo alone until progression or toxicity.
In the United States, nintedanib is available to malignant pleural mesothelioma patients only through a clinical trial.
The LUME-Meso Phase III trial of nintedanib in mesothelioma is currently recruiting in the United States at trial sites in Alabama, California, Colorado, Nevada, Pennsylvania, South Carolina, Texas, and Washington, as well as other sites worldwide. More information can be found here.
Mesothelioma patients have options when it comes to clinical trials. Click here to visit the Meso Foundation’s website where we provide a search tool for patients to find clinical trials that are currently enrolling.