Deverra Therapeutics, Inc., a biotechnology company specializing in developing advanced cell therapies for cancer and other serious diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track (FT) designation to their lead candidate, dilanubicel, for the treatment of newly diagnosed acute myeloid leukemia (AML). This designation is a significant step toward expediting the development and approval process for dilanubicel.

Dilanubicel has recently been granted Orphan Drug Designation (ODD) and Regenerative Medicine Advanced Therapy (RMAT) designation. The addition of FT designation underscores the potential of dilanubicel to address the critical unmet medical needs in treating newly diagnosed AML, where survival rates remain low.

"We are excited to receive Fast Track, Orphan Drug, and RMAT designations, which will help accelerate the development and approval process for dilanubicel in treating AML," said Dr. Colleen Delaney, MD, MSc, Chief Science Officer and EVP of Research and Development at Deverra Therapeutics. "This demonstrates a significant commitment from the FDA, and we look forward to collaborating closely with them to improve patient outcomes."

DVX101 (Dilanubicel) is an ex vivo expanded hematopoietic stem and progenitor cell product derived from pooled donor umbilical cord blood CD34+ cells. It is designed as an off-the-shelf, universal therapy, eliminating the need for donor-recipient matching. Preliminary studies have shown promising results, with statistically significant improvements in complete remission rates compared to standard chemotherapy alone, while maintaining tolerability.

Acute Myeloid Leukemia (AML) is a highly aggressive blood cancer with poor survival rates, particularly among older adults. Despite current treatments, the 5-year survival rate remains below 30 percent, highlighting the urgent need for more effective therapies like dilanubicel.

 

Source: accesswire.com

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