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News about "Breakthrough Therapy Designation (BTD) "
Enhertu Secures US BTD Status in Early HER2-Positive Breast Cancer
The US FDA has granted Breakthrough Therapy Designation to Enhertu for use as post-neoadjuvant treatment in patients with HER2-positive early breast cancer, marking the tenth such designation for AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate, supported by phase III DESTINY-Breast05 trial results.
Breakthrough Therapy Designation (BTD) | 23/12/2025 | By News Bureau
FDA Grants Priority Review to Sonrotoclax to Treat Relapsed/Refractory Mantle Cell Lymphoma
The priority review positions sonrotoclax to potentially become the first BCL2 inhibitor approved in the U.S. for relapsed or refractory mantle cell lymphoma, offering a promising new option for patients with this aggressive and hard-to-treat cancer.
Breakthrough Therapy Designation (BTD) | 28/11/2025 | By Dineshwori | 126
AbbVie Receives FDA Approval for EPKINLY Combo in Relapsed/Refractory Follicular Lymphoma
AbbVie has secured FDA approval for EPKINLY in combination with rituximab and lenalidomide (EPKINLY + R2), marking the first bispecific antibody combo therapy available for patients with relapsed or refractory follicular lymphoma after at least one prior systemic treatment.
Breakthrough Therapy Designation (BTD) | 19/11/2025 | By Dineshwori | 117
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