European Commission approves Lilly’s Portrazza for NSCLC
pharmafile | February 24, 2016 | News story | Research and Development | Eli Lilly, Portrazza
The European Commission has approved Eli Lilly’s Portrazza (necitumumab), in combination with gemcitabine and cisplatin chemotherapy, as a first-line treatment for adult patients with an advanced form of lung cancer, who have not received prior chemotherapy.
Portrazza is the first biologic licensed in the EU as a first-line treatment option for metastatic squamous non-small cell lung cancer (NSCLC): a hard-to-treat form of lung cancer, for which the five-year survival rate is less than 5%. The drug’s European approval follows that from the US FDA in November 2015. The drug was approved based on results of the Phase III SQUIRE trial, in which the combination was shown to increase median overall survival 1.6 months to 11.5 months, compared to gemcitabine and cisplatin alone.
Richard Gaynor, senior vice president of product development and medical affairs for Lilly Oncology, comments: “Today’s news means that EU patients have a new first-line treatment option for this difficult-to-treat form of lung cancer. Lung cancer is the leading cause of cancer death in the EU and there is a need for first-line treatment options, especially for squamous non-small cell lung cancer, which currently has a five-year survival rate of less than five percent for patients with metastatic disease.”
“Little progress has been made in the treatment of squamous non-small cell lung cancer in the first-line setting in the past two decades,” adds Nick Thatcher, Professor of Medical Oncology at Christie Hospital Manchester. “Nearly a third of lung cancer patients have this specific, difficult-to-treat type of cancer and a new treatment option will be welcomed by the doctors who are caring for them.”
Joel Levy
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