Menu
Home
Forums
Forums
Quick Links
Search Forums
Recent Posts
job listings
catering
whistleblower info
legal help
advertise on CP
submit press release
Menu
Log in
Sign up
Search titles only
Posted by Member:
Separate names with a comma.
Newer Than:
Search this thread only
Search this forum only
Display results as threads
More...
Useful Searches
Recent Posts
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Pharma/Biotech Companies
>
Millennium/Takeda Oncology Company
>
Wow
>
Reply to Thread
Name:
Verification:
Answer the above question:
(
CustomImgCaptcha
By
Surrey Forum
)
Message:
<p>[QUOTE="anonymous, post: 5677328"]CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited <a href="http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.takeda.com%2Finvestor-information%2F&esheet=51351208&newsitemid=20160527005319&lan=en-US&anchor=%28TSE%3A+4502%29&index=1&md5=2f069ceb123f93e1afd7e9750ff65f33" target="_blank" class="externalLink ProxyLink" data-proxy-href="http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.takeda.com%2Finvestor-information%2F&esheet=51351208&newsitemid=20160527005319&lan=en-US&anchor=%28TSE%3A+4502%29&index=1&md5=2f069ceb123f93e1afd7e9750ff65f33" rel="nofollow">(TSE: 4502)</a> today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion, recommending against the authorization of NINLARO® (ixazomib) capsules, an oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma. Takeda intends to appeal this opinion and request a re-examination by the CHMP.</p><p><br /></p><p>“We are disappointed by the CHMP’s opinion. With the support of European key medical experts, we will continue our efforts working closely with the CHMP to make NINLARO – the first oral proteasome inhibitor – available for patients in Europe,” said Christophe Bianchi, M.D., President, Takeda Oncology. “Despite recent progress, myeloma remains an intractable disease, and patients suffering from multiple myeloma and their treating physicians need more options to improve outcomes. We stand behind the TOURMALINE-MM1 trial data, which were recently published in the New England Journal of Medicine and demonstrated a significant extension in progression-free survival for NINLARO + lenalidomide and dexamethasone vs. placebo + lenalidomide and dexamethasone and a favorable benefit-risk profile.”</p><p><br /></p><p>“After years of treating patients, I have yet to see two people whose diseases are exactly alike. The diversity of patients with multiple myeloma demands a wide range of innovative treatment options that offer efficacy, tolerable safety profiles and convenience, which are especially important benefits for elderly populations,” said Philippe Moreau, M.D., University of Nantes, France. “In Europe, where no oral proteasome inhibitor is available, NINLARO would fill a noticeable void and enable the first all-oral triplet combination therapy for patients with relapsed or refractory multiple myeloma.”</p><p><br /></p><p>NINLARO was approved by the U.S. Food and Drug Administration (FDA) in November 2015 following a priority review. In the U.S., NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. The FDA approval of NINLARO marked the first global regulatory approval of ixazomib. Takeda also has submitted applications for approval of ixazomib to additional regulatory authorities around the world. In addition to the TOURMALINE-MM1 trial that is forming the basis of these global regulatory submissions in relapsed and refractory multiple myeloma, ixazomib is being investigated in a number of other multiple myeloma treatment settings.[/QUOTE]</p><p><br /></p>
[QUOTE="anonymous, post: 5677328"]CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited [URL='http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.takeda.com%2Finvestor-information%2F&esheet=51351208&newsitemid=20160527005319&lan=en-US&anchor=%28TSE%3A+4502%29&index=1&md5=2f069ceb123f93e1afd7e9750ff65f33'](TSE: 4502)[/URL] today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion, recommending against the authorization of NINLARO® (ixazomib) capsules, an oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma. Takeda intends to appeal this opinion and request a re-examination by the CHMP. “We are disappointed by the CHMP’s opinion. With the support of European key medical experts, we will continue our efforts working closely with the CHMP to make NINLARO – the first oral proteasome inhibitor – available for patients in Europe,” said Christophe Bianchi, M.D., President, Takeda Oncology. “Despite recent progress, myeloma remains an intractable disease, and patients suffering from multiple myeloma and their treating physicians need more options to improve outcomes. We stand behind the TOURMALINE-MM1 trial data, which were recently published in the New England Journal of Medicine and demonstrated a significant extension in progression-free survival for NINLARO + lenalidomide and dexamethasone vs. placebo + lenalidomide and dexamethasone and a favorable benefit-risk profile.” “After years of treating patients, I have yet to see two people whose diseases are exactly alike. The diversity of patients with multiple myeloma demands a wide range of innovative treatment options that offer efficacy, tolerable safety profiles and convenience, which are especially important benefits for elderly populations,” said Philippe Moreau, M.D., University of Nantes, France. “In Europe, where no oral proteasome inhibitor is available, NINLARO would fill a noticeable void and enable the first all-oral triplet combination therapy for patients with relapsed or refractory multiple myeloma.” NINLARO was approved by the U.S. Food and Drug Administration (FDA) in November 2015 following a priority review. In the U.S., NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. The FDA approval of NINLARO marked the first global regulatory approval of ixazomib. Takeda also has submitted applications for approval of ixazomib to additional regulatory authorities around the world. In addition to the TOURMALINE-MM1 trial that is forming the basis of these global regulatory submissions in relapsed and refractory multiple myeloma, ixazomib is being investigated in a number of other multiple myeloma treatment settings.[/QUOTE]
Your name or email address:
Do you already have an account?
No, create an account now.
Yes, my password is:
Forgot your password?
Stay logged in
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Pharma/Biotech Companies
>
Millennium/Takeda Oncology Company
>
Wow
>
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Pharma/Biotech Companies
>
Millennium/Takeda Oncology Company
>
Wow
>