May 30, 2024


Complete Canadian News World

The pharmacy gets ‘OK’ to commercialize Jebselka in Canada

Jose Maria Fernandez Sousa-Faro, President of the Pharmamar.

PharmaMar has announced the acquisition of its partner Jazz Pharmaceuticals plc Zepzelca’s conditional marketing approval (Lurbinectin) Health Canada for the treatment of adult patients Chronic stage III or metastatic small cell lung cancer, During or after disease progression Platinum based chemotherapy. Lorbinectin will be available in Canada later this year.

Based on this new approval of Lurbinectin The same clinical data from the monotherapy study, Open, multi-center and single-handed is done for 105-year-old patients Recurrent small cell lung cancer (Including patients with platinum sensitivity and platinum resistance), FDA Rapid approval of lorbenectin in the United States.

Objective response rate

The data appeared in the May 2020 issue Lancet Cancer, Recurrent small cell lung cancer, Demonstrated an objective response rate of lurbinectin (ORR) 35 percent and average response time (DoR) 5.3 months, estimated by the investigator (30 percent and 5.1 months, respectively, based on an independent review panel (IRC)).

Conditional approval is subject to confirmation in a Phase III study of small cell lung cancer In the second row, its launch is scheduled for the end of 2021.

“We are pleased to offer a new treatment option Canadian patients with persistent small cell lung cancer“, He said Jose Maria FernandezChairman of Pharmamar, “Canada The Fifth country to recognize Lorbinectin For the treatment of small cell lung cancer, it has followed in the footsteps of the United States, the United Arab Emirates and more recently Australia and Singapore. We hope that new approvals in other countries will be issued soon.

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