On April 17, takeda announced “Ixazomib citrate capsules obtains the national food and drug supervision and administration bureau (CFDA, now the SDA) issued by the drug import registration certificate, allowed to joint drug lenalidomide and dexamethasone for the treatment of always get at least one line treatment of multiple myeloma in adult patients. This is the first full oral treatment for multiple myeloma in China.
According to the review of CDE, the main basis for supporting the listing of Ixazomib in China is C16010, the global key research, and C16010 Chinese continuity research. The C16010 continuity research into the group of 115 patients in China, Ixazomib group and placebo group (placebo + drug lenalidomide + dexamethasone) of the median PFS were 6.7 and 4 months, the median OS 25.8 and 15.8 months, respectively (median follow-up of 19.8 months), ORR were 56.1% and 31% respectively. Total remission (CR) and excellent partial remission (VGPR) were 24.6% in Ixazomib group and 12.1% in the placebo group. The progress of the Ixazomib group was longer than that of the placebo group (the median was 7.3 and 4.1 months).
Ixazomib is an oral selective proteasome inhibitors, takeda is in its blockbuster boron for zc meters under pressure to launch a multiple myeloma flagship product, on November 20, 2015 for the first time the FDA approal, 2016/11/21 from the European Union for approval. If a friend reviews the registration process of Ixazomib in China, it will find that this is a very interesting case of accelerating the listing of the new drug “two to two”.