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Ixazomib (MLN9708) European approval submission

by Beacon Staff on Mon Jul 27, 2015 12:40 pm

Today's a busy day for regulatory news related to potential new myeloma thera­pies ...

We posted earlier today that the first approval filing has been made for elotuzumab. However, there's also news to be reported about ixazomib, an oral drug in the same class as Velcade and Kyprolis (proteasome inhibitors). Ixazomib was formerly known by its codename, MLN9708.

You may recall that two weeks ago, an application was submitted to the FDA to have ixazomib approved in the U.S. as a new treatment for multiple myeloma (related forum thread). Well, today it was an­nounced that an appli­ca­tion for European approval of the drug will be submitted in the next several weeks, and that it will be given an accelerated (faster than normal) review.

Here's the related press release at The Beacon.

"European Medicines Agency Grants Accelerated Assessment Of Ixazomib For Patients With Relapsed/Refractory Multiple Myeloma," Takeda press release (at The Beacon), July 27, 2015.

Beacon Staff

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