In regulatory news today, the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application from Applied Pharmaceutical Science for its breakthrough drug, APS03118, to target multiple advanced cancer types. APS03118 has intellectual property rights to target advanced cancer types caused by rearranged during transfection (RET) gene alterations. Some of these cancer types include ovarian cancer, non-small cell lung cancer (NSCLC), thyroid cancer, pancreatic cancer, colorectal cancer, breast cancer, and other advanced solid tumors. The new therapy, APS03118, is a second generation selective RET inhibitor and has been developed to target patients with resistance to first-generation RET inhibitors. RET inhibitors fall under the broader class of drugs, tyrosine kinase inhibitors (TKIs), which are commonly used anticancer drugs, and work to prevent alterations to the signal transductions associated with protein mutations that drive abnormal cancer cell growth. Applied Pharmaceutical Science is a biopharmaceutical company that focusses on the research and development of innovative cancer therapies and tumor-driven gene drugs to target leading cancers worldwide.


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