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). This means patients with malignant pleural mesothelioma in the United Kingdom can access the drug despite its lack of approval.
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.
from Mesothelioma News and Blog http://ift.tt/2FT65s4
via IFTTT
Its most exceedingly dreadful piece was that the thing just worked intermittently and the data was not right. You obviously can't go up against anyone about what you have found if the information isn't right. contact us
ReplyDeleteI can see that you are an expert at your field! I am launching a website soon, and your information will be very useful for me.. Thanks for all your help and wishing you all the success in your business. Click here
ReplyDeleteRefrigerator Repair in Lake Forest https://www.gpwlaw-mi.com/florida-mesothelioma-lawyer/
ReplyDeleteI have read your blog it is very helpful for me. I want to say thanks to you. I have bookmark your site for future updates. www.gpwlaw-mi.com/ohio-mesothelioma-lawyer/
ReplyDeleteIt proved to be Very helpful to me and I am sure to all the commentators here! Click here
ReplyDeleteThis one is good. Keep up the good work I also visit here: and I get lot of information. https://asbestoscancer.org/peritoneal-mesothelioma/
ReplyDeleteThanks for your information, it was really very helpfull.. asbestos cancer organization
ReplyDeleteI high appreciate this post. It’s hard to find the good from the bad sometimes, but I think you’ve nailed it! would you mind updating your blog with more information? Mesothelioma attorney Michigan
ReplyDeletehello!! Very interesting discussion glad that I came across such informative post. Keep up the good work friend. Glad to be part of your net community. Bethlehem Steel Shipbuilding Asbestos Claims
ReplyDelete