Lilly cancer drug gets US approval
pharmafile | November 26, 2015 | News story | | NSCLC, Portrazza, lilly, lung cancer, necitumumab, non-small cell lung cancer, oncology
Eli Lilly has received FDA approval for its monoclonal antibody Portrazza, in combination with gemcitabine and cisplatin, for patients with an advanced form of lung cancer who have had no prior treatment.
Portrazza (necitumumab) has also been granted Orphan Drug designation by the FDA, which is awarded to medicines that demonstrate promise for improving the management of rare diseases or conditions.
Metastatic squamous non-small cell lung cancer (NSCLC) is a difficult-to-treat form of lung cancer with few treatment options. The five-year survival rate for patients with metastatic disease is less than 5%.
Richard Gaynor, senior vice president of product development and medical affairs for Lilly Oncology, says: “We have seen advances in lung cancer in the last 20 years, but not for the initial treatment of patients battling metastatic squamous non-small cell lung cancer. This is a complex disease and there is an urgent need for effective, first-line treatments.
“The approval of Portrazza is an important step forward that reaffirms Lilly’s commitment to discovering new treatments that respond to the needs of individual patients.”
The safety and efficacy of Portrazza were evaluated in a study of 1,093 participants with advanced squamous NSCLC who received the chemotherapies gemcitabine and cisplatin with or without Portrazza. Those taking Portrazza plus gemcitabine and cisplatin lived an average of 11.5 months, compared to those taking only gemcitabine and cisplatin, who lived an average of 9.9 months. Portrazza was not found to be an effective treatment in patients with non-squamous NSCLC, and so was not approved for this designation.
“Lung cancer tumours can be varied, so treatment options need to be tailored to the specific type of lung cancer in the patient,” says Richard Pazdur, director of the Office of Haematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides certain patients with squamous cell lung cancer a new option that may extend survival.”
However, the treatment does come with a boxed warning for potentially serious side effects in some patients, including magnesium deficiency (hypomagnesemia), which can cause muscular weakness, seizure, irregular heartbeats and even fatal cardiac arrest and sudden death. Cardiac arrest and/or sudden death occurred in 3% of patients treated with Portrazza in combination with gemcitabine and cisplatin.
Lilly said it would provide assistance programs for eligible patients receiving Portrazza, including a co-pay program that allows qualified patients to pay no more than $25 per dose.
Joel Levy
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