On April 28, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that the U.S. Food and Drug Administration (FDA) has granted eryaspase Fast Track Designation for the development of a second-line treatment of patients with metastatic pancreatic cancer (Press release, ERYtech Pharma, APR 28, 2020, View Source [SID1234556890]).
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"This is yet another significant milestone and meaningful validation of our technology as we continue our TRYbeCA-1 Phase 3 trial evaluating eryaspase in second-line metastatic pancreatic cancer," said Gil Beyen, CEO of ERYTECH. "We believe that the FDA’s Fast Track designation for eryapase underscores its potential to address this high unmet medical need."
ERYTECH’s lead product candidate, eryaspase, is being evaluated in a Phase 3 trial (TRYbeCA-1) in second-line metastatic pancreatic cancer in 11 countries in Europe and the United States. More than 75% of the approximately 500 patients to be enrolled in the trial have been randomized. An interim superiority analysis, to be conducted by an independent data monitoring committee (IDMC) when two-thirds of the events have occurred, is currently expected to take place around year-end 2020 and the final analysis in the second half of 2021.
In a previous Phase 2b trial, eryaspase demonstrated significant improvement in both overall survival (OS) and progression-free survival (PFS) with a Hazard Ratio (HR) of 0.60 and 0.59 respectively. Overall, eryaspase was well tolerated and showed a safety profile comparable to that of standard chemotherapy.
Fast Track is a program designed to facilitate the expedited development and review of a new drug, alone or in combination with other drugs, to treat serious or life-threatening conditions for which there is a demonstration of the potential to address an unmet medical need. The purpose is to advance new drugs earlier for patients who need them.
About Pancreatic Cancer
Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. Every year, there are approximately 150,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Advanced pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate of less than 10%. It is currently the fourth leading cause of cancer death in Europe and the United States and is projected to rise to the second leading cause by 2030. Limited therapeutic options are currently available for this indication, thereby reinforcing the need to develop new therapeutic strategies and rational drug combinations with the aim of improving overall patient outcomes and quality of life.
About TRYbeCA-1
TRYbeCA-1 is a randomized, controlled Phase 3 clinical trial evaluating eryaspase in second-line metastatic pancreatic cancer. The trial is planned to enroll approximately 500 patients at approximately 100 clinical sites in Europe and the United States. Eligible patients are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab-paclitaxel or an irinotecan-based regimen) or chemotherapy alone. The primary endpoint of TRYbeCA-1 is overall survival. An interim superiority analysis will be conducted when approximately two-thirds of the events will have occurred.
About FDA Fast Track Designation
Fast Track is a program designed to facilitate the expedited development and review of a new drug alone or in combination with other drugs to treat serious or life-threatening conditions for which there is a demonstration of the potential to address an unmet medical need. The purpose is to advance new drugs earlier for patients who need them. Fast Track addresses a broad range of serious conditions. A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings and interactions with the review team at the FDA to discuss the drug’s development and ensure collection of appropriate data needed to support drug approval as well as to discuss accelerated approval, the structure and content of an NDA, and other critical issues.
More frequent written communications from FDA about such things as the design of the proposed clinical trials and use of biomarkers.
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the marketing application is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.