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A new TKI on the horizon-Radotinib approved by Korean FDA

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Hi All,

Have just been looking at what papers on CML are being presented at the ASH Conference in Orlando this week and note the topical issue of the potential for a new TKI Radotinib (IY5511HCL) to be available under the brand name Supect. It is the first drug of its kind to be developed in Asia and has already been licensed for use by the South Korean FDA..

Apparently previous studies in terms of pre clinical activity and Phase I trials on benefits and safety for treatment in CML were quite promising.A Phase II study investigated the efficacy and safety of Radotinib in treating Ph+ CML with resistance and/or intolerance to BCR-ABL1 mutations ;this was reported in the journal Haematologia July 2014.

There will be an oral presentation at ASH in session 632 under the sub head of CML Therapy and Prognosis by a group of Korean researchers and also others from  Asian countries on the results of a Phase III clinical trial.Title is "Efficacy and Safety of Radatonib compared with Imatinib in Newly Diagnosed Chronic Phase CML Patients; 12 Months result of Phase III clinical trial".

I have searched the Forum here to see if this topic has appeared before and there seems to have been brief mention of the potential new drug in the article posted by cousineg in November 2012 on "Novel agents in CML therapy:TKIs and beyond" but no other thread on this new TKI.

It will be of interest to CML patients in the  Asian region especially if priced at a reasonable level because hitherto in many countries in the region patients  could only access TKIs via private purchase or via a patient access scheme as offered by Novartis in Malaysia for instance;a former business colleague of mine from KL was funded for years so as to have free access to Imatinib at 600mg daily.Contacts in Korea told me that goverment there would not fund expensive cancer drugs under public health schemes-some patients needed to sell their houses to fund the purchase of drugs such as TKI s.

It will be interesting to see how the FDA in USA respond and the EMA in Europe-perhaps it is early days and more trials will be needed.

Sandy ,normally you post a summary of any CML related articles from ASH produced by Professor Stephen O'Brien so we look forward to this again and an opinion from a clinician of the potential of this promising TKI might be welcome.

With best wishes

John

Hi John,

thanks for this post.... there is link to ASH abstract re: a phase 3 comparative trial here:

476 Efficacy and Safety of Radotinib Compared with Imatinib in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia Patients: 12 Months Result of Phase 3 Clinical Trial

Conclusions

With minimum 12 months follow-up, radotinib demonstrated significantly higher and faster rates of CCyR and MMR than imatinib in patients with newly diagnosed CML-CP. The safety profiles of the radotinib and imatinib were different, and most AEs were manageable with optimal dose reduction. The results of this trial support that radotinib can be one of the standard of care in newly diagnosed CML-CP.

https://ash.confex.com/ash/2015/webprogram/Paper80347.html

 

I will certainly repost Prof. O'brien's ASH overview when he shares it with me.

Thanks again,

Sandy

 

Thread continued from: 
Novel Agents in CML Therapy:The Tyrosine Kinase Inhibitors and Beyond