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Daiichi Sankyo & Astrazeneca
NEWS

AstraZeneca and Daiichi Sankyo’s Enhertu Receives US FDA Priority Review for HER2+ Early Breast Cancer

Shots: FDA has granted priority review to Enhertu’s sBLA for adults with HER2+ breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment, with submission to be reviewed under Project Orbis (PDUFA: Q3’26); review is also ongoing in the EU & Japan sBLA was backed by the global P-III (DESTINY-Breast05) trial assessing Enhertu…
3 days ago

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NEWS

GAIA and Daiichi Sankyo Europe Partner to Launch Lipodia for Hypercholesterolemia in Europe

Shots: GAIA has entered into an exclusive strategic partnership with Daiichi Sankyo Europe to commercialize Lipodia, a digital therapeutic designed to support adults living with hypercholesterolemia, upon regulatory approval As per the deal, Daiichi Sankyo Europe will obtain exclusive rights to lipodia, initially covering Germany, with provisions to expand the partnership across major EU markets…
March 6, 2026

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Astrazeneca and Daiichi-Sankyo New
NEWS

Daiichi Sankyo and AstraZeneca Report the US FDA Priority Review for Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: FDA has accepted sBLA & granted priority review to Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy (PDUFA: Q2’26) sBLA was backed by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644 above-mentioned pts, which showed 5mos. improvement in…
February 3, 2026

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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports the EMA’s MAA Acceptance of Enhertu + Perjeta to Treat HER2 Positive Metastatic Breast Cancer

Shots: The EMA has validated the Type II Variation MAA for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the 1L treatment of patients with HER2+ positive unresectable or metastatic breast cancer. MAA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer…
January 19, 2026

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Daiichi Sankyo
NEWS

Daiichi Sankyo Initiates P-III (TROPIONLung17) Trial of Datroway in Nonsquamous NSCLC

Shots: Daiichi Sankyo has dosed the first patient in the P-III (TROPIONLung17) trial of Datroway for TROP2-NMR–positive LA/M nonsq. NSCLC without actionable genomic alterations previously treated with immunotherapy (IT) & Pt-based CT Trial will evaluate Datroway (6mg/kg) vs docetaxel in above-mentioned pts (n=~400) across Asia, EU & North America, assessing PFS & OS as dual…
January 14, 2026

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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINY-Endometrial02) Trial of Enhertu for HER2+ Endometrial Cancer

Shots: Daiichi Sankyo has dosed the first patient with Enhertu ± radiotherapy in the P-III (DESTINY-Endometrial02) trial, conducted in collaboration with The GOG Foundation & ENGOT, with the GINECO as the lead ENGOT group The trial will evaluate the efficacy and safety of Enhertu (5.4mg/kg) ± radiotherapy vs SoC CT (carboplatin & paclitaxel) ± radiotherapy…
December 23, 2025

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Daiichi Sankyo
NEWS

Daiichi Sankyo Reports the EMA’s MAA Validation of Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: The EMA has validated the Type II Variation MAA for Daiichi's Datroway (datopotamab deruxtecan) as monotx. For the 1L treatment of adults with unresectable or metastatic TNBC who are ineligible for PD-1/PD-L1 inhibitor therapy; additional regulatory filings are underway MAA was supported by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644…
December 19, 2025

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