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My rationale for this position is that versions 1–4 of the guide presented a single life cycle V model that was really only applicable to process equipment and manufacturing systems. I love the classification of software outlined in Appendix M4 and hate the life cycle V model. However, before we continue much further I should also declare a vested interest: I have a love–hate relationship with the GAMP guide. We will explore version 5 of the software classification and see what changes we need to make to ensure that it can be implemented practically and effectively in any laboratory. This is one of the best parts of the guide as it has an in-built risk assessment, as we shall see in this column. This publication has been available since 1994, when version 1 was informally published in the UK, and since its inception it has always contained a classification of software. Version 5 of the Good Automated Manufacturing Practice (GAMP) guide (1) was released last year. This column will look at what the changes mean for the laboratory and whether all of these should be implemented. The Guide facilitates the effective and efficient use of valuable resources by the application of appropriate and proportionate practices, encouraging innovative approaches to managing risk to patient safety, product quality, and data integrity, while supporting benefit to public health.The GAMP (Good Automated Manufacturing Practice) guide version 5 was released in March 2008 and one of the changes was that the classification of software was revised again. Technological innovation is essential for life sciences industries in providing value to society while also controlling costs and reducing time to market. The ISPE GAMP ® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems Second Edition aims to protect patient safety, product quality, and data integrity by facilitating and encouraging the achievement of computerized systems that are effective, reliable, and of high quality. GAMP ® guidance does not define a prescriptive method or a standard, but rather provides pragmatic guidance, approaches, and tools for the practitioner.
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Given that the name TNBC illustrates its lack of specifically targeted and effective therapy, we look forward to being able to retire the name in favor of a group of targetable entities within what is now called “TNBC”. Future efforts are needed to identify targetable aberrations for specific drug therapy, prevent immune evasion, and increase social-economic support. Early TNBC outcomes have improved due to the intensification of therapies, including improvements in polychemotherapy and the addition of immunotherapy. Like other breast cancers, TNBC is biologically heterogeneous, leading to diverse clinical and epidemiological behaviors, however, unlike the other clinical subtypes, in TNBC we still lack tumor-specific targeted therapy. TNBC is overrepresented among Black and pre-menopausal women and is associated with significant psychological and treatment-related burdens, including financial toxicity. It accounts for 10–15% of incident breast cancers and carries the worst prognosis. Analysts at Jefferies previously suggested that the market for previously-untreated patients alone could be worth up to $14 billion at its peak.Triple negative breast cancer (TNBC) is characterized by the lack of estrogen and progesterone receptor expression and lacks HER2 overexpression or gene amplification. Sales of Enhertu are already ramping up nicely, but could be eclipsed by the potential of Dato-DXd if it gets approved in first- and second-line NSCLC. It was the second major licensing deal between the two companies, coming after the even-bigger $6.9 billion deal for HER2-directed ADC Enhertu (trastuzumab deruxtecan) in the previous year. The phase 3 TROPION-Lung07 and AVANZAR trials started in the last few months, both seeking to expand the use of the ADC into the first-line NSCLC setting.ĪZ licensed rights to Dato-DXd in July 2020 for $1 billion upfront – paid over two years – plus up to $5 billion in regulatory and sales milestones. Meanwhile, AZ and Daiichi Sankyo have started to test Dato-DXd in late-stage studies involving previously-untreated NSCLC patients, after reporting promising results in the first-line TROPION-Lung02 study last year. The results provide further evidence of the value of targeting NSCLC with a TROP2-directed drug, after Gilead Sciences’ Trodelvy (sacituzumab govitecan) showed preliminary evidence of efficacy in a phase 1 basket study looking at multiple tumour types.Īlready approved for triple-negative breast cancer (TNBC) and bladder cancer, Trodelvy is being compared to docetaxel in the phase 3 EVOKE-01 trial in relapsed NSCLC, due to read out next year. Targeted therapies against genetic mutations and immunotherapies like Merck & Co’s Keytruda (pembrolizumab) given alone or with chemotherapy are the main first-line treatment options for advanced, metastatic NSCLC patients, but there’s still a big unmet need for patients whose disease progresses despite these therapies. The data in lung cancer follows encouraging results with Dato-DXd in breast cancer, but NSCLC is a much larger potential market and the main focus of AZ and Daiichi Sankyo’s development programme for the drug.Ĭrucially, the patient population was a mixed grouping of patients with and without genomic alterations, suggesting that Dato-DXd could end up with a broad label if this top-line data is backed up in further evaluations.ĪZ’s head of oncology R&D, Susan Galbraith, said the data challenges “the entrenched standard of care in a previously treated and unselected patient population that has long deserved an alternative to chemotherapy.” The data will now be shared with regulators to see if regulatory filings can follow. There was also an “early trend” towards an improvement in overall survival with the ADC, although that data isn’t yet mature, said the drugmakers in a joint statement. AstraZeneca and partner Daiichi Sankyo have their first phase 3 data for TROP2-targeting antibody-drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd) – in lung cancer – in one of the most keenly-anticipated phase 3 trial readouts in oncology this year.ĭato-DXd achieved a statistically significant improvement in progression-free survival (PFS) in patients with non-small cell lung cancer (NSCLC) treated with at least one prior therapy when compared with docetaxel, a standard form of chemotherapy for this group, in the TROPION-Lung01 study. When she isn’t packing for a trip away, working out, eating out or reading up on retinol serums, you’ll probably find her experimenting with her film camera and building her portfolio of portraits.įlorence’s photography can be found at florencereeves-white. 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