On August 22, 2024 Aveta Biomics, a pioneering oncology company developing first-in-class oral immuno-oncology drugs, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to APG-157, its next-generation immuno-oncology drug, for the neoadjuvant treatment of Head and Neck Cancer (HNC) (Press release, Aveta Biomics, AUG 22, 2024, View Source [SID1234646052]). This designation underscores the potential of APG- 157 to address a significant unmet medical need in treating a highly challenging form of cancer.

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The FDA’s Fast Track Designation is intended to facilitate the development and to expedite the review of drugs aimed at treating serious conditions with unmet medical needs. This designation allows for more frequent interactions with the FDA, eligibility for rolling submissions for a marketing application, and potential Accelerated Approval, ultimately aiming to bring promising new treatments to patients more rapidly.

"There is an urgent need for new treatments for head and neck cancer patients, many of whom face poor survival odds and considerable morbidities following current standard-of-care treatments, including surgery, radiotherapy, and chemotherapy/targeted treatments. The rare grant of Fast Track Designation for neoadjuvant treatment in Head and Neck Cancer underscores the FDA’s recognition of the potential role of APG-157 in providing meaningful treatment benefits to these patients," said Parag Mehta, PhD, Chief Executive Officer of Aveta Biomics.

Head and Neck Cancer affects approximately 900,000 people globally, with an overall five-year mortality rate of around 50%, a figure that has remained largely unchanged for decades. The molecular complexity of these tumors presents significant challenges for existing treatments, including targeted therapies. APG-157 is a first-in-class drug that acts through a dual mechanism: inducing selective apoptosis of cancer cells while also reprogramming the immune environment.

"This Fast Track Designation, based on our comprehensive Phase 1 and Phase 2 data, accelerates our ability to bring our promising first-line therapy to all newly diagnosed, locally advanced Head and Neck Cancer patients in a frontline setting," added Karim Malek, MD, MTh, MBA, Chief Medical Officer of Aveta Biomics.