researchers at Chalmers have shown that these metastatic cancers, that spread from the original, adapt their metabolism to the tissue in which they grow. The discovery represents a breakthrough for the understanding of metastatic cancer and is an important piece of the ...
In April 2022, the FDA granted trastuzumab deruxtecan Breakthrough Therapy Designation for the treatment of patients with HER2-low metastatic breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within 6 months of co...
patients. This Breakthrough Therapy Designation acknowledges the potential of ENHERTU to fulfill an unmet medical need and we look forward to working closely with the FDA to bring the first HER2-directed therapyto ...
Based on DESTINY-Breast04 results where AstraZeneca and Daiichi Sankyo’s ENHERTU demonstrated a significant improvement in both progression-free survival and overall survival ENHERTU has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung...
Subclonal heterogeneity and evolution in breast cancer Article Open access 21 December 2021 Interrogating breast cancer heterogeneity using single and pooled circulating tumor cell analysis Article Open access 05 July 2022 Unique evolutionary trajectories of breast cancers with distinct genomic and spa...
(palbociclib, abemaciclib and ribociclib) combined with endocrine treatment [non-steroidal aromatase inhibitors (NSAIs) or fulvestrant] not only became a standard treatment in ER+/HER2 non-amplified advanced breast cancer, but unarguably represents one of the major breakthrough in breast oncology in...
ENHERTU® (fam-trastuzumab deruxtecan-nxki) approved in the US as the first HER2-directed therapy for patients with HER2-low metastatic breast cancerPUBLISHED 5 August 2022 Based on DESTINY-Breast04 ...
we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment...
The Priority Review follows receipt of Breakthrough Therapy Designation, granted by the FDA in April 2022 for ENHERTU in metastatic HER2 low breast cancer. The sBLA is being reviewed under the Real-Time Oncology Review (RTOR) program and Project Orbis, two initiatives of the FDA which are ...
Patritumab deruxtecan was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in December 2021 for the treatment of patients with EGFR-mutated locally advanced or metastatic NSCLC with disease progression on or after treatment with a third-generation TKI and platinum-...