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Sanofi recently announced that the anti-PD-1 therapy Libtayo (cemiplimab) developed with its partner Regeneron has been approved by Health Canada as a monotherapy for the treatment of receiving a hedgehog pathway inhibitor ( HHI) Adult patients with locally advanced or metastatic basal cell carcinoma (BCC) who have been treated but have progressed or are intolerant to such drugs
.
In the United States and the European Union, Libtayo was approved for the above indications in February 2021 and June 2021, respectively
.
In addition to surgery and very limited treatment, BCC patients have few other options
Up to now, Libtayo has been approved to treat 3 kinds of advanced cancer: BCC, non-small cell lung cancer (NSCLC), skin squamous cell (CSCC)
.
CSCC and BCC are the two most common types of skin cancer.
Basal cell carcinoma (BCC) is the most common type of skin cancer in the world
.
Although the vast majority of BCC is found at an early stage and can be easily cured by surgery and radiation therapy, there are also a small number of tumors that progress to advanced stages and penetrate deep into the surrounding tissues (local progression), which is more difficult to treat
The regulatory approval of Libtayo for the treatment of locally advanced or metastatic BCC is based on data from a phase II clinical trial (NCT03132636), which represents the results of the largest prospective clinical trial conducted on these patients to date
.
The data shows: (1) In patients with metastatic BCC (mBCC), the median follow-up is 9.
Libtayo is an anti-PD-(L)1 inhibitor, which is currently a high-profile tumor immunotherapy, which aims to use the body’s own immune system to fight cancer and block the PD-1/PD-L1 signaling pathway to make cancer.
Cell death has the potential to treat many types of tumors
.
Libtayo is a fully human monoclonal antibody that targets the immune checkpoint receptor PD-1 on T cells
Libtayo uses Regeneron’s patented Velocimmune technology platform to create and optimize it.
It is currently under joint development under the framework of a global cooperation agreement between Regeneron and Sanofi for the treatment of various types of cancer
.
Libtayo's extensive clinical projects focus on refractory cancers, including skin cancer, cervical cancer, solid tumors and blood cancers
Note: The original text has been deleted
Original source: Libtayo (cemiplimab) approved in Canada for locally advanced basal cell carcinoma (BCC) patients
