Leads Biolabs' LBL-024 Receives FDA Orphan Drug Designation for Neuroendocrine Cancer
• Leads Biolabs' LBL-024, an anti-PD-L1/4-1BB bispecific antibody, has been granted Orphan Drug Designation by the FDA for neuroendocrine cancer.
• LBL-024 previously received Breakthrough Therapy Designation in China for advanced extrapulmonary neuroendocrine cancer, showing promising clinical data.
• Clinical data shows LBL-024 monotherapy more than doubled Objective Response Rate (ORR) and Overall Survival (OS) compared to existing treatments.
• The FDA's ODD provides incentives, potentially expediting LBL-024's commercialization and addressing a critical gap in neuroendocrine cancer treatment.
Leads Biolabs' LBL-024 Receives FDA Orphan Drug Designation for Neuroendocrine Cancer
• LBL-024, a bispecific antibody targeting PD-L1 and 4-1BB developed by Leads Biolabs, has been granted Orphan Drug Designation by the FDA for neuroendocrine cancer.
• This designation follows a Breakthrough Therapy Designation from China's NMPA, highlighting LBL-024's potential to improve outcomes for patients with advanced extrapulmonary neuroendocrine cancer.
• Clinical data suggest LBL-024 monotherapy has more than doubled both the Objective Response Rate (ORR) and Overall Survival (OS) compared to existing treatments for this disease.
• The Orphan Drug Designation provides incentives including tax credits, FDA guidance, and market exclusivity, potentially accelerating LBL-024's commercialization.
LBL-024 Receives FDA Orphan Drug Designation for Neuroendocrine Cancer
• LBL-024, an anti-PD-L1/4-1BB bispecific antibody developed by Leads Biolabs, has been granted Orphan Drug Designation by the FDA for neuroendocrine cancer treatment.
• The FDA's decision highlights LBL-024's potential to address unmet needs in neuroendocrine cancer, offering policy support and resource allocation for its development.
• Clinical data suggests LBL-024 could significantly improve outcomes for patients with advanced extrapulmonary neuroendocrine cancer, showing promising objective response rates.
• LBL-024 is currently in a pivotal trial for extrapulmonary neuroendocrine carcinomas, marking it as the first 4-1BB-targeted drug candidate globally to reach this stage.
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Leads Biolabs' LBL-024 Receives Breakthrough Therapy Designation in China for EP-NEC
• The CDE of China's NMPA granted Breakthrough Therapy Designation to LBL-024 for advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) post-chemotherapy.
• LBL-024, a bispecific antibody targeting PD-L1 and 4-1BB, showed remarkable efficacy and safety in EP-NEC patients who had failed second-line chemotherapy.
• Clinical data indicates LBL-024 monotherapy more than doubled both the Objective Response Rate (ORR) and Overall Survival (OS) compared to existing treatments.
• Leads Biolabs plans to aggressively pursue global clinical development of LBL-024 to provide more effective treatment options for EP-NEC patients.
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