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Drug Development in Practice – Real‑World Examples of Successful Therapeutics



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1. Introduction


While the scientific literature frequently details mechanistic studies, the true test of a therapeutic lies in its translation from bench to bedside. The following concise review highlights two landmark drugs—Pembrolizumab (Keytruda®) and Sotorasib (Lumakras®)—whose development pathways exemplify how laboratory discoveries are shepherded through pre‑clinical validation, phased clinical trials, regulatory approval, and ultimately, patient benefit.



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2. Pembrolizumab (PD‑1 Inhibitor)



Stage Key Milestones & Data


Discovery Identification of PD‑1/PD‑L1 checkpoint pathway in 1992–2000; discovery that blocking this interaction restores T‑cell activity against tumors.


Pre‑clinical In vitro assays showed PD‑1 blockade increases cytotoxic lymphocyte proliferation; murine models demonstrated tumor regression (median survival increase >30 days).


Phase I (2010) Dose‑escalati

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