Look @ this FDA accelerated approval days ago:
Post# of 152645
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Posted On: 05/09/2025 7:32:19 PM
Look @ this FDA accelerated approval days ago:
*FDA approves the Avmapki Fakzynja combination therapy as the first-ever treatment for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer.
*The open-label, multicenter trial enrolled adult patients with measurable KRAS-mutated recurrent LGSOC (n = 57).
*The median duration of treatment with the combination was 12 months (range, 0.03-40). Serious toxicities were reported in 32% of patients. Dose interruptions and reductions due to an adverse effect (AE) were experienced by 84% and 44% of patients, respectively. AEs led to permanent discontinuation of the doublet for 14% of patients.
https://www.onclive.com/view/fda-approves-avu...ian-cancer
Phase 2 & only 57 patients.
Shortly post May 15th, no reason an LL approval is not released...
*FDA approves the Avmapki Fakzynja combination therapy as the first-ever treatment for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer.
*The open-label, multicenter trial enrolled adult patients with measurable KRAS-mutated recurrent LGSOC (n = 57).
*The median duration of treatment with the combination was 12 months (range, 0.03-40). Serious toxicities were reported in 32% of patients. Dose interruptions and reductions due to an adverse effect (AE) were experienced by 84% and 44% of patients, respectively. AEs led to permanent discontinuation of the doublet for 14% of patients.
https://www.onclive.com/view/fda-approves-avu...ian-cancer
Phase 2 & only 57 patients.
Shortly post May 15th, no reason an LL approval is not released...
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