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News about "Breakthrough Therapy Designation "
Akeso Secures Fifth NMPA Breakthrough Designation for Ivonescimab
The breakthrough designation supports ivonescimab combined with chemotherapy for first-line treatment of advanced Biliary Tract Cancer (BTC), based on an ongoing phase-III study comparing it with durvalumab-based chemotherapy.
Breakthrough Therapy Designation | 07/02/2026 | By News Bureau
Immix Biopharma Gets US FDA Breakthrough Therapy Designation for NXC-201
Immix Biopharma has received US FDA Breakthrough Therapy Designation for its CAR-T candidate NXC-201, based on positive interim phase-II results from the NEXICART-2 study presented at the ASH 2025 annual meeting, with final data expected later this year followed by a planned Biologics Licence Application (BLA) submission.
Breakthrough Therapy Designation | 29/01/2026 | By News Bureau
Bayer Secures Breakthrough Status for Sevabertinib in HER2 NSCLC
US FDA and China’s CDE granted the designation for sevabertinib as a potential first-line therapy in advanced HER2-mutant non-small cell lung cancer.
Breakthrough Therapy Designation | 07/01/2026 | By News Bureau | 135
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 | 134
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 | 362
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 | 109
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 | 162
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 | 136
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 | 476
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 | 745
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