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News about "Breakthrough Therapy Designation "
Akeso's Ivonescimab Wins 4th Breakthrough Therapy Nod in China for TNBC
Akeso has secured its fourth Breakthrough Therapy Designation (BTD) in China for Ivonescimab, targeting first-line treatment of triple-negative breast cancer (TNBC). The ongoing Phase III HARMONi-BC1 trial is assessing its safety and efficacy in this hard-to-treat cancer type.
Breakthrough Therapy Designation | 03/11/2025 | By Dineshwori
Jascayd is the first and only preferential inhibitor of phosphodiesterase 4B (PDE4B) to be approved in this indication. This represents a novel mechanism of action that exerts both antifibrotic and immunomodulatory effects, thereby slowing the decline in lung function in IPF patients.
Breakthrough Therapy Designation | 10/10/2025 | By Dineshwori | 171
US FDA Grants Priority Review for Enhertu + Pertuzumab in HER2+ Metastatic Breast Cancer
The US FDA has granted Priority Review to Enhertu + Pertuzumab for HER2+ metastatic breast cancer, following DESTINY-Breast09 trial results showing a 44 percent reduction in risk of disease progression or death and over three years’ median Progression-Free Survival (PFS), positioning it as a potential new first-line standard of care.
Breakthrough Therapy Designation | 25/09/2025 | By Dineshwori
FDA Grants BTD to Raludotatug Deruxtecan for Platinum-Resistant Ovarian Cancer
This is the first BTD granted for Raludotatug Deruxtecan, the second for the Daiichi Sankyo-Merck partnership and the 15th across Daiichi Sankyo’s oncology portfolio, marking a significant milestone in the companies’ joint efforts to develop innovative cancer therapies.
Breakthrough Therapy Designation | 16/09/2025 | By Dineshwori | 101
AstraZeneca's Imfinzi Granted Priority Review by FDA for Early-Stage Gastric and GEJ Cancers
The US Food and Drug Administration (FDA) has accepted AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) and granted Priority Review for the treatment of patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.
Breakthrough Therapy Designation | 28/07/2025 | By Dineshwori | 113
Arrowhead Pharmaceuticals Secures FDA Breakthrough Therapy Designation for Plozasiran
Arrowhead intends to submit a New Drug Application to the FDA by year-end 2024 and plans to seek regulatory approval with additional global regulatory authorities thereafter.
Breakthrough Therapy Designation | 13/09/2024 | By Aishwarya | 437
AusperBio Gets BTD for AHB-137 in Chronic Hepatitis B Treatment
AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. have announced that their investigational drug AHB-137 has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.
Breakthrough Therapy Designation | 11/07/2024 | By Aishwarya | 564
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