Enrollment discontinued in SELECT-AML-1 Ph 2 trial of tamibarotene + venetoclax & azacitidine in newly diagnosed, unfit AML patients with RARA gene overexpression August 22, 2024
Ph 3 SIERRA trial deemed inadequate to support BLA filing for Iomab-B; additional head-to-head RCT demonstrating OS benefit required August 22, 2024
FDA provides IND requirements for the development of ALA-101 in first-inhuman clinical trials for lymphoma and leukaemia August 13, 2024
Fixed-duration Calquence + venetoclax, with or without obinutuzumab, significantly improved PFS in 1L CLL in AMPLIFY Ph 3 trial August 7, 2024
PDUFA Action Date Extension Announced for Revumenib NDA for R/R KMT2Ar Acute Leukemia; new PDUFA action date: Dec 26, 2024 August 7, 2024
Pivotal, adaptive MIRACLE Ph 3 trial designed for possible accelerated approval of Annamycin + cytarabine for the treatment of R/R AML August 7, 2024
Scemblix® Granted FDA Priority Review For The Treatment Of Adults With Newly Diagnosed CML based on ASC4FIRST Ph 3 study data August 6, 2024
Fixed-duration Calquence plus venetoclax, with or without obinutuzumab, significantly improved PFS in 1L CLL in AMPLIFY Ph 3 trial July 30, 2024
FDA Grants Orphan Drug and Rare Pediatric Disease Designation Status to UCART22 product candidate for ALL Treatment July 30, 2024
Regulatory path forward for uproleselan in R/R AML would require an additional clinical trial July 30, 2024
Ph 2 volasertib program receives “Clearance to Proceed” from the FDA and agreement on the dosing plan for Ph 2 clinical trial July 30, 2024
U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to SLS009 for the Treatment of Pediatric AML July 23, 2024
Ph 1/2 dose-escalation study of SP-2577 in combination with azacitidine in adults with MDS and CMML Placed on Partial Hold July 17, 2024
HREC Approval and CTN Clearance granted from the TGA to Commence a Ph 1 Clinical Trial for INT2104 for B Cell Malignancies July 17, 2024
FDA Rare Pediatric Disease Designation Granted to SLS009 for the Treatment of Pediatric ALL July 1, 2024
