Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years
Evrysdi is approved in 70 countries and submitted in a further 31 with more than 4,500 patients treated to date
Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year
Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone
DOVBLERON marks the 13th addition to Innovent’s commercial portfolio
In 2020, CORXEL acquired the rights to develop and commercialize aficamten in Greater China
Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients
If approved, Blenrep (belantamab mafodotin) in combinations with BorDex (BVd) and PomDex (BPd) could redefine multiple myeloma treatment at or after first relapse
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