Yuhan | MedPath

Australia's TGA Denies Second Approval Attempt for Eisai's Alzheimer's Drug Leqembi

3 months ago

• Australia's Therapeutic Goods Administration (TGA) has rejected Eisai's Alzheimer's treatment Leqembi (lecanemab) for the second time, raising questions about access to novel Alzheimer's therapies in the region. • Leqembi, an anti-amyloid antibody therapy that received FDA approval in 2023, has shown significant reduction in clinical decline in early Alzheimer's patients in clinical trials. • The decision highlights the varying regulatory approaches to novel Alzheimer's treatments across different global markets, impacting patient access to emerging therapies.

J&J's Carvykti Shows Promise in Earlier Myeloma Treatment

5 months ago

• The CARTITUDE-4 study indicates that Carvykti (ciltacabtagene autoleucel) significantly improves progression-free survival in multiple myeloma patients with 1-3 prior lines of therapy. • Carvykti, a BCMA-directed CAR-T therapy, may soon be used earlier in the treatment pathway, potentially leapfrogging Bristol-Myers Squibb's Abecma. • The study compared Carvykti to standard three-drug regimens, showing a significant benefit that led to unblinding of the trial. • Expansion of Carvykti's use is a key component of J&J's strategy in multiple myeloma, alongside other therapies like Darzalex and bispecific antibodies.