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Antengene Announces its U.S. Partner, Karyopharm Therapeutics Inc., has received FDA Approval of XPOVIO® (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Therapy

December 21, 2020
Oral XPOVIO® Approval as Combination Therapy in Patients with Multiple Myeloma After At Least One Prior Therapy Significantly Expands the XPOVIO® Addressable Patient Population -
Oral XPOVIO® is Now the Only Approved Multiple Myeloma Drug Indicated as Part of a Once-Weekly Bortezomib Combination Regimen -
First Multiple Myeloma Drug with a New Mechanism of Action Approved by the FDA in the Second-Line Setting Since 2016 -
FDA Approval Comes Approximately Three Months Ahead of Target PDUFA Date -
SHANGHAI and HONG KONG, Dec. 21, 2020 /PRNewswire/ Antengene Corporation Limited ( Antengene , SEHK: 6996.HK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) submitted by its partner Karyopharm Therapeutics Inc. (Nasdaq: KPTI) for oral XPOVIO ....

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FDA Approves Selinexor Combination Treatment for Certain Patients With Multiple Myeloma

FDA Approves Selinexor Combination Treatment for Certain Patients With Multiple Myeloma
pharmacytimes.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmacytimes.com Daily Mail and Mail on Sunday newspapers.

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Karyopharm Announces FDA Approval of XPOVIO® (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Therapy

Karyopharm Announces FDA Approval of XPOVIO® (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Therapy
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Antengene Announces Approval of IND Application in China for a Phase 3 Clinical Trial of ATG-010 (Selinexor) in Combination with Bortezomib and Dexamethasone (SVd) for the Treatment of rrMM

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SHANGHAI and HONG KONG, Dec.18, 2020 /PRNewswire/ Antengene Corporation Limited ( Antengene , SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for ATG-010 (selinexor), an oral Selective Inhibitor of Nuclear Export compound, in combination with bortezomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (rrMM) in China.
The trial is a Phase 3 randomized, controlled, open-label, multicenter clinical trial, aiming to evaluate the efficacy and safety of ATG-010, bortezomib and dexamethasone (SVd) regimen against bortezomib and dexamethasone (Vd) regimen in Chinese adult patients with rrMM who have received one to thr ....

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Karyopharm Appoints Michael Mano as Senior Vice President, General Counsel and Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Published: Dec 15, 2020

NEWTON, Mass., Dec. 15, 2020 /PRNewswire/ Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced the appointment of Michael Mano as Senior Vice President, General Counsel. Mr. Mano brings over 15 years of legal experience and previously served as Counsel, Business Development at Biogen Inc.
Michael s depth of legal experience, particularly in the public life science sector supporting partnerships, intellectual property licensing, corporate governance, and financing efforts, will be valuable to Karyopharm as we continue to grow our commercial business and work to expand the reach of XPOVIO and our other pipeline assets worldwide, said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. ....

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