Benzinga | Oct 29, 2021 07:19AM EDT

Libtayo Approved In Canada For Locally Advanced Basal Cell Carcinoma Patients

Libtayo(r) (cemiplimab) is now approved in Canada for the treatment of adults with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI).2 The approval of Libtayo follows the European Commission (EC) approval announced in June 2021 and the US in February 2021.3

"This is a game changer for patients with advanced basal cell carcinoma who no longer have treatment options," says Dr. Marcus Butler, University Health Network. "Again, we are finding that immunotherapy can benefit patients who previously had no options. Immunotherapy continues to be a pillar of cancer therapy."

With today's announcement, Libtayo is now offered as an immunotherapy option for three 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.4

"Canadians living with advanced basal cell carcinoma are in urgent need of access to new therapeutic options to treat this elusive yet serious skin cancer," says Kathy Barnard, skin cancer survivor and founder of Save Your Skin Foundation. "We applaud Health Canada's approval of Libtayo, which provides new hope for patients and their loved ones."

"Patients with locally advanced basal cell carcinoma face significant life-threatening challenges, including the physical and emotion devastation of the disease," says Annette Cyr, founder and chair of board of directors, Melanoma Network of Canada. "Beyond surgery and very limited therapeutic treatments, there are few options currently available. Today's approval of Libtayo by Health Canada provides a treatment option that gives our patient community and their families reason to hope."