South Korea approves Antengenes first-in-class cancer drug Selinexor

Antengene Corporation Limited, a prominent biopharmaceutical company recently announced to have received an approval by the South Korean Ministry of Food and Drug Safety (MFDS) for New Drug Application (NDA) for the Orphan Drug-designated first-in-class oral inhibitor XPO1, selinexor.

The drug can be used together with dexamethasone for treating adult patients with relapsed or refractory multiple myeloma (rrMM). The patients should have received minimum four prior therapies with their disease refractory to not less than two proteasome inhibitors, with an anti-CD38 monoclonal antibody and minimum two immunomodulatory agents.

It can be used as a monotherapy for treating adults with refractory/relapsed diffuse large B-cell lymphoma (rrDLBCL) who have gone through least two prior lines of treatment.

Many patients with MM subsequently suffer from relapse or turn into refractory diseases. For patients who have failed in one therapy, diffuse large B-cell lymphoma (DLBCL) has low prognosis and their chance of cure or long-term disease-free survival is reduced after each treatment. Currently, there is no remedy for rrMM and rrDLBCL and it is in acute need for safer and improved therapies.

For the record, in October 2020, Orphan Drug Designation (ODD) was given to selinexor drug in South Korea, which was defined based on the MFDS as therapies used for treating diseases affecting 20,000 or less patients and therapies used for treating diseases for which no appropriate therapy has been developed, or therapies that have shown substantial improvement in safety or efficacy in comparison to existing treatments.

Selinexor's innovative mechanism of action (MoA) which is predicated on the selective inhibition of the nuclear export protein XPO1, is diverse as compared to all presently approved therapies. The drug can be used together with various therapies to provide improved treatment outcomes in these diseases. 

Many international multicenter clinical trials using selinexor are being carried out in North America, Europe, Australia, Asia.

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