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Antengene announced ATG-010 (selinexor) granted priority review by China's NMPA
24 Feb 2021
ATG-010 (Selinexor, XPOVIO – Selective inhibitor of nuclear export (SINE)) – Karyopharm Therapeutics/ Antengene
- Antengene was granted priority review for ATG-010 by NMPA for NDA approval in the treatment of patients with RRMM in China
- Patient enrolment for the registrational clinical trial in RRMM in China is completed
- Antengene has submitted NDAs for ATG-010 in five APAC markets including Australia, South Korea and Singapore over the past six months
China's NMPA granted priority review to first and only SINE compound (selinexor)
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CI Scientists Remarks:
- About the molecule: ATG-010 (selinexor) is a oral selective inhibitor of nuclear export (SINE) compound discovered and developed by Karyopharm Therapeutics. It is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including Greater China, South Korea, Australia, New Zealand and the ASEAN countries
- Selinexor is approved as XPOVIO in the US for MM & DLBCL and has conditional approval in Europe for RRMM
- Results from Phase 3 BOSTON study: Selinexor + bortezomib + dexamethasone (N=195) vs bortezomib + dexamethasone (N=207) in patients with RRMM:
- ORR: 76.4%
- PFS: 47%
- Peripheral neuropathy of grade 2 or above: 21% vs 34%
- Grade 3–4 adverse events: Thrombocytopenia 39% vs 17%, fatigue 13% vs 1%, anaemia 16% vs 10%, and pneumonia 11% vs 11%
- US FDA approved Selinexor for 3 indications within 18 months, expecting the similar trend, Antengene has submitted multiple NDAs in different countries and is also conducting Phase 3 SIENDO trial in patients with endometrial cancer
– Dr. Kowndinya, CI Scientists