Regeneron and Sanofi pull Libtayo app in cervical cancer, citing post-market study disagreement with FDA
Sanofi and Regeneron on Friday said they’ve decided to pull their sBLA for their PD-1 Libtayo (cemiplimab-rwlc) in second-line cervical cancer after the companies and the FDA were not able to align on certain post-marketing studies that presumably would’ve been required had it won approval.
Neither Sanofi nor Regeneron was willing to elaborate on this disconnect over the post-marketing requirements, but talks with regulators outside the US remain 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 in a note on the announcement Friday. “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.”
Truist also noted that other companies may find challenges in pursuing evolving and competitive therapeutic landscapes such as this one, particularly as “it becomes more difficult to recruit for these confirmatory and post-marketing studies in a reasonable time,” which companies “may think it’s not worth the investment.”
Earlier this week, Incyte said it made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.
Friday’s news for Sanofi and Regeneron came as a surprise as the companies previously halted a Phase III cervical cancer trial early after Libtayo was shown to cut the risk of death by 31% over chemotherapy, paving the way for this priority review submission (the PDUFA date was Jan. 30).
A Regeneron spokesperson confirmed that the company was not amending its statement from March regarding the trial results.
The trial win in March followed a string 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.
Invented with Regeneron’s proprietary VelocImmune tech, Libtayo has shown significant sales growth in recent years, as it’s approved for certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma (CSCC), and advanced non-small cell lung cancer.
Regeneron, which records net product sales of Libtayo in the US, reported about $340 million in Libtayo sales in the first nine months of 2021, a 34% increase over 2020.
And Sanofi, which records net product sales of Libtayo outside the US, said sales amounted to €59 million ($66 million) in the first half of 2021, driven by increased demand in the treatment of metastatic CSCC and by the launch of the product for that indication in new countries.
