A kwadoro ọgwụgwọ ọrịa cancer cervical metastatic ugbu a

Today sanofi-aventis Canada Inc. (Sanofi) announced the approval of Libtayo® (cemiplimab) for the treatment of adult patients with cervical cancer who have progressed on or after prior platinum-based chemotherapy and who require additional systemic therapy to treat recurrent or metastatic disease. The approval is based on the Phase 3 EMPOWER-Cervical 1 Study of Cemiplimab in Adults With Cervical Cancer (NCT03257267). The trial, which was the largest-ever randomized clinical trial in advanced cervical cancer, included patients with recurrent or metastatic cervical cancer whose histology was either squamous cell carcinoma or adenocarcinoma. Participants were randomized to receive either cemiplimab or the investigator’s choice of chemotherapy. The primary endpoint for the trial was overall survivali.             

Mark Surka, Ph.D, Oncology Medical Head, Sanofi Canada: “While rates of cervical cancer in Canada are thankfully decliningii, due in large part to the effectiveness of the HPV vaccine in preventing cervical pre-cancers from formingiii, Canada still sees 1400 women diagnosed with this disease every yeariv and who need treatment options. We’re proud to have brought Libtayo to approval for the women who are diagnosed with recurrent or metastatic cervical cancer, and the healthcare professionals who treat them.”

Fourth indication for Libtayo in difficult-to-treat cancers

With today’s announcement, Libtayo is now approved as an immunotherapy option for four advanced cancers:

•             In April 2019, Libtayo became the first immunotherapy option in Canada for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.

•             In October 2021, the availability of Libtayo was expanded to include adults with advanced non-small cell lung cancer expressing PD-L1 in ≥ 50% of tumour cells (Tumour Proportion Score [TPS] ≥ 50%), as determined by a validated test, with no EGFR, ALK or ROS1 aberrations who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC.

•             Also in October of 2021, Libtayo was approved for the treatment of adults with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI).