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Prestige Biopharma Collaborates with Biosidus to Commercialize Tuznue (Biosimilar, Herceptin) Across LATAM

Shots: Prestige Biopharma has entered into an exclusive license & supply agreement with Biosidus to commercialize Tuznue, a biosimilar version of Herceptin (trastuzumab) across Latin American markets, incl. Argentina, Mexico, Bolivia, & Paraguay As per the deal, Biosidus gains exclusive rights to market & distribute Tuznue in Argentina, Mexico, Bolivia & Paraguay, while Prestige Biopharma…

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Genentech

Genentech (Roche) Reports Interim P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early Breast Cancer

Shots: Genentech has reported P-III (lidERA Breast Cancer) trial assessing giredestrant (QD) vs SoC endocrine therapy in pts (n=~4,100) with medium or high-risk stage I-III ER+, HER2- breast cancer Trial met its 1EP of improved invasive disease-free survival & showed a favorable OS trend; OS data remains immature. Results to be presented in future meetings…

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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 recurrence Trial showed improved invasive disease-free survival (1EP), while OS (2EP) was immature during interim…

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Eli lilly

Eli Lilly’s Inluriyo (Imlunestrant) Receives the US FDA’s Approval for ESR1-mutated Breast Cancer

Shots: FDA approved Inluriyo (200mg; PO) for treating adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy; US availability expected in the coming wks. Approval was based on P-III (EMBER-3) trial (N=874: 32% in 1L & 64% in 2L treatment post progression) assessing Inluriyo ± abemaciclib vs fulvestrant/exemestane…

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Eli lilly

Eli Lilly Reports Topline P-III (monarchE) Trial Data of Verzenio (Abemaciclib) to Treat Early Breast Cancer

Shots: Eli Lilly has reported topline P-III (monarchE) trial data assessing Verzenio (150mg, BID) + SoC adj. ET vs SoC adj. ET in 2 cohorts (N=5,637) for pts with HR+, HER2-, node-positive early breast cancer at high risk of recurrence Cohort 1 (n=5,120; FDA-approved) incl. pts with ≥4 positive nodes or 1–3 nodes plus tumor ≥5…

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Novartis

Novartis Reports the Health Canada’s Approval of Kisqali (Ribociclib) for the Treatment of HR+/HER2- Early Breast Cancer

Shots: Health Canada has approved Kisqali (ribociclib) + an aromatase inhibitor (AI) for adj. treatment of adults with HR+/HER2-, stage II-III early breast cancer (EBC) at high risk of recurrence Approval was supported by global P-III (NATALEE) study assessing Kisqali + AI vs AI alone as an adj. treatment of pts (n=5101) with stage II & III…

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