FRANCE – Regeneron Pharmaceuticals Inc and its partner Sanofi voluntarily withdrew their application to the US Food and Drug Administration to expand the use of their anti-cancer drug Libtayo in patients with advanced cervical cancer.
The application for the monoclonal antibody as a second-line treatment in patients was withdrawn “after the companies and the United States Food and Drug Administration were unable to align on certain post-marketing studies,” the companies said.
Neither Sanofi nor Regeneron would comment on the disparity in post-marketing requirements, but discussions with regulators outside the US are ongoing.
“We’re noticing a pattern with FDA on non-alignment on post-marketing studies, which creates uncertainty for drugmakers,” investment analysts at Truist Securities said.
“FDA is not making the path forward easier. It could be because there are other drugs coming down the pipeline that are potentially better and safer, which raises the bar.”
Incyte announced earlier this week that it had made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3K inhibitor, after determining that running the confirmatory studies requested by the FDA to support an accelerated approval wouldn’t be worth it.
Sanofi and Regeneron were taken aback by the news, as the companies had previously halted a Phase III cervical cancer trial early after Libtayo was shown to reduce the risk of death by 31% compared to chemotherapy, paving the way for this priority review submission.
Each year, an estimated 570,000 people are diagnosed with cervical cancer worldwide, with over 250,000 deaths.
A Regeneron spokesperson confirmed that the company was not changing its March statement about the trial results.
The March trial win was the culmination of two quick approvals that came within weeks of each other, vastly expanding Libtayo’s label and, for the first time, pitting it against Merck’s dominant PD-1-star Keytruda.
About Libtayo
Libtayo is a fully human monoclonal antibody that specifically targets the immune checkpoint receptor PD-1 on T-cells.
Libtayo works by preventing cancer cells from using the PD-1 pathway to suppress T-cell activation by binding to it.
Libtayo, which was developed using Regeneron’s proprietary VelocImmune technology, has seen significant sales growth in recent years, as it is now approved for certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma (CSCC), and advanced non-small cell lung cancer.
However, the use of Libtayo in advanced cervical cancer is not approved by the FDA.
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