The EC Granted Conditional Approval for Regeneron and Sanofi Product Libtayo for CSCC
The European Commission (EC) conditional approval for Regeneron Pharmaceuticals’ (REGN) and Sanofi’s (SNY) product Libtayo® (cemiplimab) is a historical event and a game changer in the prognosis of metastatic and locally advanced cutaneous squamous cell carcinoma (CSCC).
Before the approval of Libtayo patients with advanced CSCC , who are not candidates for curative surgery or curative radiation, had no specific treatment that would bring hope of halting their cancer’s growth and saving their lives.
CSCC is common and caused by exposure to ultraviolet (UV) radiation found in sunlight, commercial tanning lamps and tanning beds. The good news is that this skin cancer can be avoided by not subjecting the skin to ultraviolet (UV) radiation. It can be easily treated if discovered and managed early. Surgery, radiation and local treatments, which are available, do very well against these early diagnosed cutaneous cancers.
If CSCC is not treated early, it becomes aggressive; eating into the patients’ flesh and, in some instances, metastasizing into other cells and organs becoming life-threatening. Before the approval of Regeneron’s/Sanofi’s monoclonal antibody Libtayo, the patients had no approved drugs to bring the hope of a cure or survival.
The Newly Approved Product, Libtayo
Libtayo, which has been granted conditional approval In Europe, is a fully-human monoclonal antibody for advanced and metastatic CSCC. This antibody targets the immune checkpoint receptor programmed death protein-1 (PD-1). We reiterate that this immunotherapy checkpoint inhibitor product is the only approved therapy for advanced CSCC in the EU.
Updated data from the registrational EMPOWER-CSCC-1 trial were announced at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. The EC approval is based on data from the pivotal, open-label, multi-center, non-randomized Phase 2 trial EMPOWER-CSCC-1 (Study 1540) and supported by two advanced CSCC expansion cohorts from a multi-center, open-label, non-randomized Phase 1 trial (Study 1423).
The recommended dose of Libtayo is 350 mg every 3 weeks administered by intravenous infusion over 30 minutes. Treatment may be continued until disease progression or unacceptable toxicity.
About the Conditional Approval for Libtayo
As part of the conditional approval, Regeneron and Sanofi will add a new patient group to EMPOWER-CSCC-1 to further support the benefit-risk profile of Libtayo, and report the results to the European Medicines Agency (EMA). As is standard practice for conditional approvals the EMA reviews new information at least every year and updates product labeling as necessary.
Libtayo is also being investigated in adjuvant and neoadjuvant trials in CSCC and in potential registrational trials in non-small cell lung cancer, basal cell carcinoma and cervical cancer. Additional studies include trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin’s lymphoma, and non-Hodgkin’s lymphoma.
These trials are investigating Libtayo as monotherapy in combination with conventional treatments like chemotherapy, or in combination with other investigational agents, including vaccines, oncolytic viruses and bispecific antibodies, among others.
When no treatments exist for an advanced life-threatening disease the first product to be approved for the disease becomes historical and considered a game changer in the prognosis of the disease.
In Europe, Libtayo will represent an important new option for patients with advanced CSCC who cannot be saved by surgery or radiation. As mentioned above, advanced skin cancer is easy to conquer when in early stages; however, no treatment is available to conquer it in its advanced stages, which torture the patients and threaten their lives. So, Regeneron’s product Libtayo is a unique, life-savior and, hence, should be expected to become a best seller.
Regeneron also has many recently approved products. It does not make sense that, with the expected generation of billions of dollars in revenues, the stock continues to be in the oversold territory. We believe that the time has come for REGN to recuperate its past losses and move towards their proper territory.
We are optimistic about Regeneron’s scientific and drug development performances and about the breakthrough nature of many of its pipeline products.
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