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Thursday, December 3, 2020

Karyopharm/Antengene submits applications for Xpovio in Asia-Pac for blood cancer

 

  • Antengene has submitted new drug applications (NDA) for XPOVIO (selinexor, ATG-010) being co-developed by Karyopharm Therapeutics (NASDAQ:KPTI) to the regulatory authorities in Singapore and Australia for the treatment of adult patients with relapsed or refractory multiple myeloma ("rrMM") and refractory diffuse large B-cell lymphoma ("rrDLBCL"), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.
  • The NDA of Antengene has already been accepted in Australia on December 2, 2020. NDA for XPOVIO (selinexor) has also been submitted in Hong Kong for the treatment of adult patients with rrMM.
  • Antengene is conducting two registrational Phase 2 clinical trials of XPOVIO in China for rrMM (MARCH) and for rrDLBCL (SEARCH), and has initiated clinical trials for high prevalence cancer types in the Asia Pacific region including peripheral T-cell lymphoma and NK/T-cell lymphoma (TOUCH) and KRAS-mutant non-small cell lung cancer (TRUMP).
  • https://seekingalpha.com/news/3641293-karyopharm-therapeutics-antengene-submits-applications-for-xpovio-in-asia-pacific-region-for

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