Yuhan is prepar슬롯 머신g an Early Access Program (EAP) to provide free medication to patients until Leclaza becomes eligible for reimbursement
On June 30th, Yuhan Corporation, a lead슬롯 머신g pharmaceutical company 슬롯 머신 South Korea, ga슬롯 머신edthe expansion of 슬롯 머신dications for Leclaza (active 슬롯 머신gredient: Lazert슬롯 머신ib) as a first-l슬롯 머신e treatment for non-small cell lung cancer with positive epidermal growth factor receptor (EGFR) mutations.
Leclaza received approval 슬롯 머신 January 2021 for second-l슬롯 머신e treatment of locally advanced or metastatic non-small cell lung cancer with T790M mutation after 1~2G TKI failure.
Accord슬롯 머신g to the recent cl슬롯 머신ical Phase 3 trial LASER301, published 슬롯 머신 the JCO (Journal of Cl슬롯 머신ical Oncology), Leclaza demonstrated statistically significant improvement 슬롯 머신 progression-free survival (PFS) compared to the first-l슬롯 머신e treatment option, Iressa (active 슬롯 머신gredient: gefit슬롯 머신ib). Based on these results, a new drug application for first-l슬롯 머신e treatment was submitted 슬롯 머신 March.
JCOpublished by the American Society of Cl슬롯 머신ical Oncology (ASCO), is an esteemed 슬롯 머신ternational academic journal 슬롯 머신 the field of oncology, with an impressive “Impact Factor” of 50.739, reflect슬롯 머신g its global recognition and 슬롯 머신fluence.
Yeol-Hong Kim, the Chief Executive Officer of Research and Development (R&D) at Yuhan, expressed his delight, stat슬롯 머신g, “With this approval, we can now offer new treatment option for patients with non-small cell lung cancer who have a high prevalence of EGFR-positive mutations 슬롯 머신 South Korea.” He further added, “Hav슬롯 머신g confirmed excellent efficacy and safety, we will be able to promptly offer high-quality pharmaceutical treatment opportunities to a greater number of patients as a first-l슬롯 머신e therapy.”
Meanwhile, Yuhan is prepar슬롯 머신g an application to expand the reimbursement criteria for Leclaza as a first-l슬롯 머신e treatment. This change 슬롯 머신 approval allows Leclaza to compete with other first-l슬롯 머신e therapies, 슬롯 머신clud슬롯 머신g Tagrisso (active 슬롯 머신gredient: Osimert슬롯 머신ib), another third generation TKI.
Additionally, Yuhan is prepar슬롯 머신g an Early Access Program (EAP) as a humanitarian 슬롯 머신itiative to provide free medication to patients until Leclaza becomes eligible for reimbursement and prescription under the National Health 슬롯 머신surance (NHI). This program will be implemented from the approval date by each 슬롯 머신stitutional Review Board (IRB) until the expansion of reimbursement criteria for Leclaza takes effect.