1/3/2024 0 Comments Apg trackingThis FTD for alrizomadlin will lead to a series of benefits that could accelerate the clinical development and review for this drug candidate, including more frequent communications and meetings with the FDA during its clinical development and if the FDA determines appropriate, to be allowed to enter Rolling Review, a process that allows a company to submit New Drug Applications (NDAs) by sections, rather than waiting until all required materials become available. The FTD expedites the development and review of drug candidates to treat serious diseases/conditions that present urgent unmet clinical needs. The cohort of patients with PD-1/PD-L1 inhibitor-resistant melanoma treated with alrizomadlin in combination with pembrolizumab achieved one case of complete response (CR), an objective response rate (ORR) of 24.1%, and a disease control rate (DCR) of 55.2%. The preliminary clinical data released in an oral report at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting showed that alrizomadlin has favorable antitumor activity and a manageable safety profile. This FTD for alrizomadlin is based on combined preclinical results and preliminary clinical data from an ongoing Phase II study (APG-115-US-002, Identifier: NCT03611868). Therefore, patients who failed on or developed acquired resistance to ICIs are in urgent need of new treatment options. Although approximately 35% to 60% of the patients have a response evaluation criterion in solid tumors (RECIST) response to ICIs, the remaining 40% to 65% have shown minimal or no RECIST response at the outset, and 43% of the responders develop acquired resistance in the three years after receiving ICIs 4. Immune checkpoint inhibitors (ICIs) are currently recommended for the first-line treatment of most patients with metastasized melanoma 3. ![]() ![]() Advanced melanoma presents an enormous clinical challenge as it is prone to metastasis and lacks survival benefit from chemotherapies. In 2019, an estimated 96,480 patients have been diagnosed with melanoma and about 7,230 patients with melanoma have died in the United States 2. The current lifetime risk of developing melanoma is 1 in 63 in the US 1. Melanoma is a potentially deadly dermatologic malignancy that has been increasingly prevalent globally.
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