FDA approves Portrazza for specific type of lung cancer

In its latest round of cancer drug approvals, FDA last week approved Portrazza (necitumumab) in combination with 2 forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC).

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Manufactured by Eli Lilly & Co., Portrazza injection for intravenous use (800 mg/50 mL), in combination with gemcitabine and cisplatin, is the first biologic for the first-line treatment of people with metastatic squamous non-small cell lung cancer (NSCLC).

Metastatic squamous NSCLC is a difficult-to-treat form of lung cancer with few treatment options. The 5-year survival rate for patients with metastatic disease is less than five percent, according to Eli Lilly & Co.

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"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," said Richard Gaynor, MD, senior vice president, product development and medical affairs for Lilly Oncology.

Eli Lilly & Co. is committed to offering assistance programs for eligible patients receiving Portrazza, including a copay program that allows qualified patients to pay no more than $25 per dose.

The approval of Portrazza, which has been granted orphan drug designation by FDA, was based on a multicenter, randomized, open-label clinical 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 longer on average (11.5 months) compared to those only taking gemcitabine and cisplatin (9.9 months). Portrazza was not found to be an effective treatment in patients with non-squamous NSCLC.

The most common side effects of Portrazza are skin rash and magnesium deficiency (hypomagnesemia), which can cause muscular weakness, seizure, irregular heartbeats and can be fatal. Portrazza includes a boxed warning to alert health care providers of serious risks of treatment with Portrazza, including cardiac arrest and sudden death, as well as hypomagnesemia.

Patients, physicians, pharmacists or other healthcare professionals with questions about Portrazza should contact The Lilly Answers Center at 1-800-LillyRx (800) 545-5979 or visit www.lilly.com.

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