Datopotamab deruxtecan

Datopotamab deruxtecan's BLA accepted in the US for treating metastatic HR-positive, HER2-negative breast cancer, based on Phase III trial results showing significant PFS improvement over chemotherapy. FDA decision expected Q1 2025.

Daiichi Sankyo and AstraZeneca's Biologics License Application for datopotamab deruxtecan, a TROP2 directed ADC, was accepted in the U.S. for treating advanced nonsquamous NSCLC post-systemic therapy. Based on TROPION-Lung01 trial results, it showed significant PFS improvement over docetaxel, with a favorable OS trend. FDA decision expected by December 20, 2024.

AstraZeneca and Daiichi Sankyo's BLA for datopotamab deruxtecan (Dato-DXd) was accepted in the US for treating advanced nonsquamous NSCLC post-systemic therapy, based on TROPION-Lung01 Phase III trial results showing improved PFS over docetaxel. FDA decision expected Q4 2024. Ongoing trials aim to establish Dato-DXd as a new standard in NSCLC treatment.

In 2023, FDA's CDER approved 55 new drugs, a five-year high. Key 2024 drug launches include KarXT for schizophrenia, Donanemab for Alzheimer's, Resmetirom for NASH, Sotatercept for PAH, Datopotamab deruxtecan for lung & breast cancer, Acoramidis for ATTR-CM, mRNA-1345 for RSV, Anktiva for NMIBC, Ensifentrine for COPD, and Imetelstat for MDS.

Clarivate's 2024 Drugs to Watch report highlights 13 new therapeutics expected to achieve blockbuster status by 2029, targeting conditions like sickle cell disease, RSV, and breast cancer. It also notes the growing chronic disease market in China and the impact of new technologies like CRISPR-Cas9 and AI in drug development.