Key Takeaways AZN's oncology sales hit $5.6B in Q1 2025, up 13%, led by drugs like Tagrisso, Imfinzi, and Enhertu. Truqap and Datroway launches in HR HER2- breast cancer show early sales strength and FDA momentum. AZN eyes pipeline growth with late-stage drugs camizestrant and volrustomig across multiple cancer types.AstraZeneca (AZN) is one of the leading drugmakers in the oncology space. Oncology sales (comprising around 41% of AstraZeneca‘s total revenues) rose 13% in the first quarter of 2025, generat ...

Key Takeaways FDA approved Datroway for EGFR-mutated NSCLC after prior systemic and EGFR-directed therapies. Approval is backed by phase II and III studies showing a 45% objective response rate with Datroway. Datroway was first approved for breast cancer, gaining two U.S. indications within six months.AstraZeneca (AZN) announced that the FDA has expanded the label of its cancer drug Datroway for a second indication — non-small cell lung cancer (NSCLC). The drug has been developed in partnership with Japan ...

AstraZeneca (AZN) stock has declined 6.4% in the past three months.Although AstraZeneca faces its share of challenges, a significant portion of this price decline is attributed to broader market uncertainties and a volatile macroeconomic environment.The sky-high tariffs imposed by the United States and retaliatory tariffs by China and some other countries hurt global stock markets. Though the massive tariffs imposed by the United States and China are now on a pause, it is only a temporary suspension, and no ...

Core Insights - Merck and Daiichi Sankyo have initiated the phase III IDeate-Esophageal01 study for the B7-H3 directed ADC, ifinatamab deruxtecan (I-DXd), targeting advanced or metastatic esophageal squamous cell carcinoma (ESCC) patients [1][2] - The study aims to compare the safety and efficacy of I-DXd against an investigator's choice of chemotherapy in patients who have progressed after platinum-based therapy and immune checkpoint inhibitors [2] - The primary endpoint is overall survival, with secondary endpoints including progression-free survival and objective response rate [3] Company Developments - Merck's stock has decreased by 22.3% year-to-date, while the industry has seen a decline of 5.2% [6] - Merck acquired global co-development and co-commercialization rights for I-DXd and two other ADCs from Daiichi Sankyo for a potential total of up to $22 billion, retaining exclusive rights for Daiichi in Japan [8] - Merck has expanded its collaboration with Daiichi to co-develop MK-6070, a T-cell engager targeting DLL3, following its acquisition of Harpoon Therapeutics [9] Industry Context - ADCs are viewed as a disruptive innovation in the pharmaceutical industry, enhancing cancer treatment by using antibodies to deliver cytotoxic drugs directly to tumors [11] - Daiichi Sankyo is developing several ADCs across various cancer types, including Enhertu, which is marketed in partnership with AstraZeneca [12] - Pfizer has entered the ADC market by acquiring Seagen for $43 billion, adding three ADCs to its portfolio that have significantly contributed to its revenues in 2024 [13][14]

Core Viewpoint - Roche has received FDA Breakthrough Device Designation for the VENTANA® TROP2 (EPR20043) RxDx Device, marking a significant advancement in computational pathology companion diagnostics for oncology [1][2]. Group 1: Product Details - The VENTANA TROP2 (EPR20043) RxDx Device utilizes artificial intelligence to enhance sample analysis, providing a quantitative TROP2 score for non-small cell lung cancer (NSCLC) tissue [2][8]. - The device integrates the TROP2 algorithm, navify® Digital Pathology Image Management System, and Roche Digital Pathology scanners, along with the VENTANA TROP2 RxDx Assay [2][5]. - It is specifically designed to identify patients with previously treated advanced or metastatic non-squamous NSCLC who are most likely to benefit from treatment with the DATROWAY® (datopotamab deruxtecan-dlnk) [5][8]. Group 2: Technological Innovation - The algorithm employs AstraZeneca's Quantitative Continuous Scoring (QCS) platform, which enhances diagnostic precision beyond traditional manual methods [3][6]. - The device's AI-driven image analysis allows for a more accurate assessment of TROP2 IHC staining intensity, leading to the computation of the Normalised Membrane Ratio (NMR) score [6][8]. Group 3: Market Implications - The Breakthrough Device Designation may expedite the availability of the TROP2 CDx AI-driven system, facilitating timely identification of NSCLC patients who could benefit from targeted therapies [4][8]. - This designation reflects Roche's ongoing commitment to innovation in companion diagnostics and digital pathology, aiming to improve precision in oncology diagnoses [2][8].