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Astrazeneca and Daiichi-Sankyo New
NEWS

Daiichi Sankyo and AstraZeneca Report CHMP Positive Opinion for Enhertu + Perjeta to Treat HER2-Positive Metastatic Breast Cancer

Shots: The CHMP has recommended Enhertu (5.4mg/kg) + Perjeta for the 1L treatment of pts with HER2+ unresectable or metastatic breast cancer (MBC), backed by P-III (DESTINY-Breast09) trial data (n=1157) Trial assessed Enhertu ± Perjeta vs THP, where it improved PFS by 44% in 383 pts who had not received prior CT or HER2-targeted therapy,…
12 hours ago

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Pfizer New
NEWS

Pfizer’s Ibrance Combination Receives FDA Approval as a Maintenance Therapy for HR+, HER2+ Metastatic Breast Cancer

Shots: The US FDA has approved Pfizer's Ibrance (palbociclib) + trastuzumab ± pertuzumab, & endocrine therapy for the maintenance treatment of adults with HR+, HER2+ locally advanced or metastatic breast cancer following induction treatment Approval was based on the AFT-sponsored P-III (PATINA) trial, where pts receiving a median of 6 cycles of induction treatment were…
June 25, 2026

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Pfizer New
NEWS

Pfizer Reports P-II (FOURLIGHT-1) Trial Data on Atirmociclib Combination for 2L Metastatic Breast Cancer

Shots: Pfizer has reported P-II (FOURLIGHT-1) trial data assessing atirmociclib + fulvestrant vs fulvestrant or everolimus plus exemestane in 264 pts with HR+, HER2- advanced or metastatic breast cancer who had received prior CDK 4/6 inhibitor-based treatment Trial met its 1EP, showing improved PFS as assessed by the investigator, with benefit consistent across all subgroups. OS…
March 17, 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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NEWS

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…
November 26, 2025

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Pfizer New
NEWS

Pfizer Reports Topline P-III (HER2CLIMB-05) Trial Data of Tukysa (Tucatinib) in Metastatic Breast Cancer (MBC)

Shots: Pfizer has reported P-III (HER2CLIMB-05) trial data assessing Tukysa (n=326) vs PBO (n=328), both in combination with trastuzumab & pertuzumab, as a maintenance therapy for pts with HER2+ MBC following induction therapy in the 1L setting Trial met its 1EP with a significant improvement in the investigator-assessed PFS & showed favorable safety; data to…
October 15, 2025

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Briacell
NEWS

BriaCell Reveals P-II Trial Data of Bria-IMT Regimen for Metastatic Breast Cancer

Shots: BriaCell has reported P-II trial data comparing Bria-IMT + check point inhibitors (CPI) to Trodelvy's historical data in heavily pre-treated pts (n=54) with late-stage metastatic breast cancer 37 HR+ breast cancer pts of P-II trial were treated with the ongoing pivotal P-III (BRIA-ABC) trial formulation of Bria-IMT, showing favorable survival data Trial showed 25/37…
April 17, 2025

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Daiichi Sankyo & Astrazeneca
NEWS

Daiichi Sankyo and AstraZeneca Report the US FDA’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC), Progressed on Endocrine Therapies

Shots: The US FDA’s approval of Enhertu for HR+, HER2 low/ultralow MBC, progressed on endocrine therapies, was based on P-III (DESTINY-Breast06) study compared to CT shared at ASCO 2024 & published in The NEJM. AZ will pay $175M for this milestone Study depicted PFS of 36%, mPFS of 13.2 vs 8.1mos., cORR of 62.6%…
January 28, 2025

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Top Performing Drug – Perjeta (January Edition)
INSIGHTS+

Top Performing Drug – Perjeta (January Edition)

Shots:   In continuation of our previous series on the Top-Performing Drug of the month, based on 2021 revenue, this month we have selected Perjeta and prepared a curated analysis report for our readers  Perjeta is indicated for the treatment of HER2-positive metastatic breast cancer, neoadjuvant HER2-positive breast cancer, Adjuvant HER2-positive breast cancer PharmaShots presents a concise…
January 30, 2024

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