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CAR-T Digest - August 2020

CAR-T Digest - August 2020

CAR-T Digest - August 2020

CAR-T Digest - August 2020

Regulatory

Regulatory
FDA approved Oncopeptides´ PEPAXTO for relapsed triple-class refractory multiple myeloma

Multiple myeloma – March 2021 Multiple myeloma – March 2021 FDA approved Oncopeptides´ PEPAXTO (melphalan flufenamide) for patients with relapsed triple-class refractory multiple myeloma 01 Mar 2021 PEPAXTO (melphalan flufenamide/ melflufen – Peptide-drug conjugate) – Oncopeptides FDA has approved PEPAXTO […]

by Sandhya Ramalingam

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Regulatory
Sanofi’s Sarclisa steps closer towards second approval in MM with CHMP positive opinion

Multiple myeloma – March 2021 Multiple myeloma – March 2021 CHMP recommended approval of Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma 26 Feb 2021 Sarclisa (Isatuximab – Anti-CD38 monoclonal antibody) […]

by Sandhya Ramalingam

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Regulatory
First and only SINE compound (Selinexor) steps closer to China approval

Multiple myeloma – March 2021 Multiple myeloma – March 2021 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 […]

by Sandhya Ramalingam

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Regulatory
China’s NMPA granted BTD for IASO Bio/Innovent’s CT103A in RRMM

Multiple myeloma – March 2021 Multiple myeloma – March 2021 IASO Bio/Innovent’s CT103A granted BTD by the China’s NMPA for the treatment of RRMM 22 Feb 2021 CT103A (BCMA-directed CAR T cell therapy) – IASO Biotherapeutics/ Innovent The BTD designation […]

by Sandhya Ramalingam

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