Regenerative meta/Sanofi PD-1 inhibitors were given a second adaptive disorder

Today, Regeneron and Sanofi jointly announced that the FDA has approved the PD-1 inhibitor Libtayo (cemiplimab) extended adaptation to treat patients with advanced substrate cell carcinoma (BCC).
patients have previously been treated with hedgehog pathfage inhibitors (HHI) or are not suitable for HHI treatment.
press release that Libtayo is the first immunotherapy to be approved to treat this type of cancer.
substrate cell carcinoma is a common non-melanoma skin cancer.
Although the vast majority of substrate cell carcinomas are detected early and can be easily cured by surgery and radiotherapy, a small number of tumors can progress to deeper surrounding tissue (local progression) or spread to other parts of the body (metastasis), making it more difficult to treat.
the United States alone, about 2 million new cases of substrate cell carcinoma are diagnosed each year, 20,000 patients have advanced substrate cell carcinoma and 3,000 will die from the disease.
Libtayo is an all-humanized anti-PD-1 monoclonal antibody that, by binding to PD-1 on T cells, Libtayo has been shown to prevent cancer cells from using PD-1 signaling path pathps to inhibit the activity of T cells.
it has been approved by the FDA for the treatment of metastatic skin squamous cell carcinoma (CSCC) or locally advanced CSCC patients who cannot undergo curative surgery or radiotherapy.
also shown good results in Phase 3 clinical trials in patients with non-small cell lung cancer.
approval is based on an open-label, multi-center, non-randomized Phase 2 clinical trial.
112 patients were included in the efficacy analysis.
results showed that Libtayo achieved a confirmed objective remission rate (ORR) of 21% in patients with metastasis BCC.
in patients with late-stage local BCC, Libtayo achieved an objective remission rate of 29%, of which the total remission rate was 6%.
" FDA approval today of Libtayo will change the treatment model for patients with advanced substrate cell carcinoma.
," said Dr. Karl Lewis, a professor of oncology at the University of Colorado.
currently the main systemic treatment option is hedgehog inhibitors, but many patients end up with disease progression or inability to be resistant to the treatment.
Libtayo offers these patients a new option for immunotherapy, which has shown clinically significant long-lasting anti-tumor activity.
: This article is intended to introduce medical and health research, not treatment options recommended.
if you need guidance on treatment options, visit a regular hospital.
references: (1) FDA APPROVES LIBTAYO ® (CEMIPLIMAB-RWLC) AS FIRST IMMUNOTHERAPY INDICATED FOR PATIENTS ADVANCED BASAL CELL CARCINOMA. Retrieved February 9, 2021, from