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Daiichi Sankyo and Merck Report the P-II Study Data for Raludotatug Deruxtecan in Pt.-Resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Shots:Daiichi Sankyo and Merck reported efficacy results for raludotatug deruxtecan (R-DXd) in patients with recurrent Pt.-resistant ovarian, primary peritoneal, or fallopian tube cancer from the P-II (dose-optimization) part of the REJOICE-Ovarian01 P-II/III studyAcross all doses (4.8 mg/kg, 5.6 mg/kg, and 6.4 mg/kg), ORR was 50.5% (n=107) as assessed by BICR, with 3 complete…

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Daiichi Sankyo

Daiichi Sankyo Reports the MHLW’s sNDA Submission of Enhertu + Perjeta to Treat HER2+ Breast Cancer

Shots:Japan’s MHLW has received the sNDA of Enhertu + pertuzumab for the treatment of pts with HER2+ unresectable or recurrent breast cancersNDA 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 pts (n=1157), which showed improved PFS by 44%,…

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Astrazeneca and Daiichi-Sankyo New

AstraZeneca and Daiichi Sankyo Report P-III (TROPION-Breast02) Trial Results of Datroway for Triple-Negative Breast Cancer

Shots:The global P-III (TROPION-Breast02) trial assessed Datroway vs CT in 644 pts with previously untreated locally recurrent inoperable or metastatic TNBC, regardless of PD-L1 expression, for whom immunotherapy was not an optionTrial showed Datroway significantly improved OS & PFS vs CT in TNBC pts; data to be presented in a future meeting &…

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Astrazeneca and Daiichi-Sankyo New

Daiichi Sankyo and AstraZeneca Report the Topline P-III (DESTINY-Breast05) Trial Data of Enhertu for High-Risk Early Breast Cancer

Shots:The global P-III (DESTINY-Breast05) trial data assessed Enhertu (trastuzumab DXd; 5.4mg/kg) vs trastuzumab emtansine in 1,635 HER2+ primary breast cancer pts with residual invasive disease in breast or axillary lymph nodes after neoadj. therapy & a high risk of recurrenceTrial showed improved invasive disease-free survival (1EP), while OS (2EP) was immature during interim…

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Astrazeneca & Daiichi Sankyo

Daiichi Sankyo and AstraZeneca Receive the US FDA’s Priority Review for Enhertu + Perjeta to Treat HER2+ Breast Cancer

Shots:The US FDA has accepted sBLA & granted priority review to Enhertu + Perjeta for the 1L treatment of adults with unresectable or metastatic HER2+ breast cancer, which will be reviewed under RTOR pathway (PDUFA: Jan 23, 2026)sBLA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta…

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Merck and Daiichi Sankyo’s Raludotatug deruxtecan Receives FDA’s Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or Fallopian Tube Cancers 

Shots:The US FDA has granted BTD to Raludotatug deruxtecan (R-DXd) for the treatment of adults with Pt-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with AvastinDesignation was based on P-I trial (n=179) & the ongoing P-II/III (REJOICE-Ovarian01) trial (n=~710), with subgroup analysis of P-I presented at…

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Daiichi Sankyo

Daiichi Sankyo Reports the EMA’s MAA Acceptance of Enhertu to Treat Solid Tumors

Shots:The EMA has validated the Type II Variation MAA for Enhertu (trastuzumab deruxtecan) to treat previously treated adults with HER2+ (IHC 3+) unresectable or metastatic solid tumors, who have unsatisfactory alternative treatment optionsMAA was supported by 3 P-II (DESTINY-PanTumor02, DESTINY-CRC02 & DESTINY-Lung01) trials, where DESTINY-PanTumor02 (n=267, incl. 111 HER2+ pts) assessed Enhertu (5.4mg/kg)…

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Top 20 Oncology Companies of 2025 

Shots: ADCs, cell therapies, and radioligand therapies are reshaping oncology, while biopharma companies focus on smarter trials, patient-first approaches, and faster access to bridge unmet needs in cancer care In 2024, the global oncology market was valued at $225.01B and is projected to reach $668.26B by 2034, reflecting a strong CAGR of 11.5% from 2025…

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Daiichi Sankyo and Merck Dose First Patient in P-III (HERTHENA-Breast04) Trial of Patritumab Deruxtecan to Treat HR+/HER2- Breast Cancer

Shots:The first patient is dosed in P-III (HERTHENA-Breast04) trial (n=~1000) of patritumab deruxtecan (HER3-DXd; 5.6mg/kg) vs CT/Enhertu for unresectable LA/M, HR+, HER2- breast cancer after progression on endocrine & CDK4/6 inhibitor therapy in either adjuvant or 1L metastatic settingsHERTHENA-Breast04 was initiated based on findings from P-II (ICARUS-Breast01) & a P-I/II breast cancer study published…

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