RE:RE:RE:RE:RE:RE:“Second mouse gets the cheese “ In June 2023 the US Food and Drug Administration (FDA) accepted Ipsen's supplemental new drug application (sNDA) for the Onivyde regimen as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) patients.
The review is based on positive results from the pivotal Phase III NAPOLI 3 trial, in which the Onivyde regimen demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS), compared to nab-paclitaxel plus gemcitabine, with a safety profile consistent with the profiles of the treatment components. These results were presented at the January 2023 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI).
The Onivyde regimen comprises Onivyde (irinotecan liposome injection) along with 5-fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen).
The regulator has set 13 February 2024 as a Prescription Drug User (PDU) Fee Act goal date for the review of Ipsen’s sNDA.
In 2020, the FDA granted Ipsen Fast Track designation for Onivyde as a first-line combination treatment for mPDAC. The FDA’s Fast Track program facilitates the development and expedites the review of medicines that treat serious conditions and have the potential to address an unmet medical need.
Correspondingly, in December 2022 the FDA also granted ONCY Fast Track designation for pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab and the chemotherapy agents gemcitabine and nab-paclitaxel in the treatment of mPDAC.
So as posted beforehand " ... the boats are a shaking ..."
https://www.newswire.ca/news-releases/oncolytics-biotech-r-receives-fda-fast-track-designation-for-the-treatment-of-advanced-metastatic-pancreatic-cancer-882925259.html
https://www.ipsen.com/press-releases/correction-ipsen-announces-u-s-fda-submission-acceptance-of-its-supplemental-new-drug-application-for-onivyde-regimen-in-first-line-metastatic-pancreatic-ductal-adenocarcinoma/