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Author: Admin | 2025-04-28
IntroductionOncological drug development is one of the most important area in drug development. Cancer incidence is expected to rise significantly through 2050, and more than 2,000 new oncology clinical trials started in 2023 with novel modalities and significant promise for cancer treatment, including cell and gene therapies, antibody-drug conjugates, multi-specific antibodies, and radioligand therapies [1]. Many cancer types share common molecular pathways for tumorgenesis, cell proliferaion and metastasis [Signaling pathways in cancer metabolism: mechanisms and therapeutic targets. Signal Transduct Target Therapy. 2023;8(1):196." href="https://link.springer.com/article/10.1007/s43441-024-00718-2#ref-CR2" id="ref-link-section-d91346872e348">2]. So that, in most cases, a drug candidate is developed as potentially effective against multiple cancer types. Given the constraints of industrial research and development (R&D) resources and the different probability of development success for each cancer type, the order and timing of obtaining approval for each indication is an important component of lifecycle management (LCM) for pharmaceutical companies [3].It is a crucial R&D decision for pharmaceutical companies to target and initiate the clinical development of a new oncological drug, given the science level pertinent to the product, medical needs, regulation, and economic and business prospects. The choice of lead indication is critical for a company’s development strategy. The market for anticancer drugs is fragmented by indication, and competition with rival products occurs in such fragmented markets. New molecular entities are granted marketing exclusivity in the US for five or seven years for the first indication approved, depending on orphan designation status. Companies can also benefit from the remaining effective patent period. From the perspective of obtaining regulatory approval, a common strategy is first to develop orphan indications, which are treated favorably in various ways upon approval, even though the market is small, and then expand the indications to other types of cancer with larger markets. The choice of the first indication thus plays a critical role in maximizing the probability of development success and promoting market penetration of the drug [4, 5].The potential target indication of a new drug is determined by several factors that define the ‘druggability,’ including the physical and chemical properties of the drug and its pharmacological targetability considering the cancer biology.
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