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Adcendo ApS has received FDA Fast Track designation for its first-in-class antibody-drug conjugate (ADC), ADCE-D01, aimed at treating soft tissue sarcoma. This designation acknowledges the drug's potential to address a high unmet medical need and will expedite its development and regulatory review process. ADCE-D01, which targets the uPARAP receptor overexpressed in mesenchymal cancers, is currently undergoing Phase I/II clinical trials in the US and Europe.

In a nutshell

The FDA's Fast Track designation for ADCE-D01 provides critical validation of Adcendo's therapeutic approach and significantly accelerates the development timeline for this promising oncology candidate. This regulatory advancement offers a faster potential path to market, which is crucial for patients with limited treatment options in soft tissue sarcoma.

Source: PR Newswire UK