Sanofi/Regeneron’s immunotherapy Libtayo has scored approval from the US Food and Drug Administration (FDA) for the treatment of certain patients with advanced basal cell carcinoma (BCC) – the most common type of skin cancer in the US.
The FDA has indicated Libtayo (cemiplimab-rwlc) for the treatment of previously-treated, advanced BCC patients who have already received a hedgehog pathway inhibitor (HHI) or who cannot be treated with an HHI.
The PD-1 inhibitor has been granted a full approval for patients with locally advanced BCC and accelerated approval for patients with metastatic BCC, which has spread to other parts of the body.
“Thanks to the participation and support of researchers, clinicians, and patients around the world, we are proud to bring forward a new immunotherapy treatment option for appropriate patients in the US affected by advanced BCC, another devastating non-melanoma skin cancer,” said Peter Adamson, global development head, oncology and paediatric innovation at Sanofi.
The full approval for Libtayo in locally advanced BCC is based on the primary analysis from a Phase II trial of the treatment, while the accelerated approval in metastatic BCC is based on an interim analysis.
In metastatic BCC, patients receiving Libtayo achieved a 21% overall response rate (ORR), while locally advanced BCC patients demonstrated ORR of 29%.
“Together with Regeneron, we continue to develop Libtayo in numerous clinical trials and settings, including as monotherapy and in combination with several other therapeutic approaches as part of our commitment to innovation towards meaningful treatment options for patients with significant unmet needs,” added Adamson.