FDA Approves Portrazza for Advanced Squamous NSCLC

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FDA Approves Portrazza for Advanced Squamous NSCLC
FDA Approves Portrazza for Advanced Squamous NSCLC

WEDNESDAY, Nov. 25, 2015 (HealthDay News) -- Portrazza (necitumumab), in combination with two other chemotherapy drugs, has been approved by the U.S. Food and Drug Administration to treat advanced squamous non-small-cell lung cancer (NSCLC), the agency said Tuesday in a news release.

Portrazza, approved for patients who haven't had a previous therapy for squamous NSCLC, is designed to block activity of the epidermal growth factor receptor protein, the agency explained.

The drug was evaluated in combination with two other drugs, gemcitabine and cisplatin. Those who took the three-drug combination lived for an average of 11.5 months, compared to 9.9 months among those who took the other two drugs without Portrazza.

Portrazza's most common side effects included skin rash and hypomagnesemia. The drug's label includes a boxed warning that the latter can cause potential fatal complications, including seizures and irregular heartbeat, the FDA said.

Portrazza is marketed by Indianapolis-based Eli Lilly.

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