Lilly will be breathing a sigh of relief after US regulators issued a green light for its lung cancer drug Portrazza, having been satisfied that its potential benefits outweigh its risks.
The drug, a monoclonal antibody blocking the activity of EGFR, can now be used to treat patients with advanced squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for their disease, offering access to a biologic treatment for the first time.
Metastatic squamous NSCLC is notoriously difficult to treat with few treatment options, and patients with metastatic disease face a five-year survival rate of less than five percent.
Approval was based on trial data showing that Portrazza (necitumumab) improves survival, with patients taking the drug plus gemcitabine/cisplatin living on average 11.5 months compared to 9.9 months for those taking only the chemotherapies.
But safety flags were also raised after clinical data also showed the incidence of thromboembolic events to be raised in patients taking Lilly’s drug. As such, its label carries a boxed warning to alert healthcare providers of serious risks of treatment, including cardiac arrest and sudden death, as well as hypomagnesemia.
"Lung cancer is an extremely complicated disease that requires a variety of therapy options so doctors can choose an appropriate treatment for each patient's unique circumstances," said lung cancer survivor Bonnie Addario, founder and chair of the Bonnie J. Addario Lung Cancer Foundation. Portrazza’s approval “represents progress for patients diagnosed with metastatic squamous non-small cell lung cancer, as each new therapy advances cancer care and gives patients hope for improved outcomes,” she noted.