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Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA’s sNDA Acceptance of Inqovi + Venetoclax for Newly Diagnosed AML

Shots:The US FDA has accepted sNDA of Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, ineligible for intensive induction CT (PDUFA: Feb 25, 2026)sNDA was backed by P-IIb (ASCERTAIN-V) trial in 101 adults with newly diagnosed AML ineligible for intensive induction CT, where pts…
2 days ago

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Vertex Pharmaceuticals
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Vertex Presents Long-Term CLIMB Trial Program Data of Casgevy (Exagamglogene Autotemcel) to Treat Hemoglobinopathies at EHA 2025

Shots:The global P-I/II/III (CLIMB-121 & 111) trials assessed Casgevy in sev. SCD & TDT pts (12–35 yrs), with 2yr. post-infusion follow-up, after which pts entered the ongoing 15yr. CLIMB-131 trial, with SCD pts followed for >5.5yrs & TDT for >6yrs.In SCD, 43/45 pts were VOC-free for ≥12mos., with mean VOC-free duration of 35mos.…
July 4, 2025

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Johnson& Johnson
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Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma

Shots: J&J has reported P-II (RedirecTT-1) trial data on Talvey (talquetamab-tgvs) + Tecvayli (teclistamab-cqyv) in 90 heavily pretreated r/r MM pts with extramedullary disease, where 84.4% were triple-class refractory, 35.6% penta-drug refractory, 20% had prior BCMA CAR-T, & 8.9% had prior bsAb exposureTrial showed a 78.9% ORR, with 54.4% achieving CR or better, incl.…
June 16, 2025

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Novartis
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Novartis to Highlight P-IIIb Trial Data of Fabhalta for Paroxysmal Nocturnal Hemoglobinuria (PNH) at EHA 2025

Shots:Novartis has reported P-IIIb (APPULSE-PNH) trial data assessing Fabhalta (iptacopan; 200mg, BID, PO) for 24wks. in 52 PNH adults with Hb levels ≥10g/dL who switched from anti-C5 therapies (eculizumab or ravulizumab)Trial showed a 2.01 g/dL mean Hb increase, with 92.7% pts achieving ≥12g/dL & no transfusions over 24wks. It also depicted improved fatigue…
June 12, 2025

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