Fast Track Designation Granted by the U.S. FDA for VCN-01 for the Treatment of Metastatic Pancreatic Cancer
“The FDA’s decision to grant FTD to VCN-01 highlights the urgent need for new treatment options for PDAC, which accounts for the 4th highest cause of cancer-associated deaths in the US and Europe,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “VIRAGE, our Phase 2b trial evaluating VCN-01 in metastatic PDAC continues to progress, with enrollment expected to complete in the third quarter of 2024. FTD is an important step that furthers our ability to expedite the review of, and build upon the compelling clinical data that underscores VCN-01’s multiple modes of action and therapeutic potential in combination with chemotherapy or immunotherapy. We will continue to deliver on our mission to advance new therapeutic options for these patients.”
Share:
More News
“Between 2017 and 2023, the socioeconomic burden of HER2-positive breast cancer in ten major economies was nearly $590 billion, projected to increase to nearly $1,000 billion by 2032,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “At-home treatment may help alleviate the pressure
Richard Saynor, CEO of Sandoz, said: “The global burden of cancer continues to grow and the potential to address unmet patient needs has never been greater. This agreement offers us the chance to reach many more millions of patients, while helping to drive the long-term sustainability of healthcare systems.”
“Beyond the second-line monotherapy opportunity, we and our partners at Pfizer have removed plans for a Phase 3 first-line combination trial with atirmociclib, as well as the planned Phase 3 second-line combination trial with a CDK4/6 inhibitor, from our joint development plan,” continued Dr. Houston. “This decision was made following
“The interim PFS analysis results demonstrated that, compared to the current standard treatment, KN026 in combination with chemotherapy significantly improved PFS, reduced the risk of disease progression or death, and showed a trend toward OS benefit. Detailed data from this study will be presented at an upcoming international academic conference.”
