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FDA Panel: Lung Cancer Drug Necitumumab Has Positive Risk/Benefit Profile

Advisors support approval despite blood clot risk

The FDA’s Oncologic Drugs Advisory Committee has effectively supported approval of the investigational lung-cancer treatment necitumumab (Eli Lilly) but has recommended that measures be taken to mitigate the drug’s risks, according to a Reuters report.

Necitumumab is a second-generation monoclonal antibody for patients with stage-IV squamous non–small-cell lung cancer (NSCLC).

The panel did not officially vote, but an informal poll taken by the FDA indicated that most members believe the drug’s benefits outweigh its risks.

In a clinical trial involving 1,093 patients with NSCLC, those treated with necitumumab along with the chemotherapy drugs gemcitabine and cisplatin survived an average of 11.5 months compared with 9.9 months for patients treated with gemcitabine and cisplatin alone. Although the necitumumab improved overall survival, it also increased the risk of sometimes-fatal blood clots and potentially deadly electrolyte imbalances.

Most panel members described the drug’s survival benefit as modest but meaningful and in line with the benefit conferred by other FDA-approved therapies.

A decision on approval is pending by the end of the year.

Lilly currently markets Cyramza (ramucirumab), a drug for the treatment of NSCLC in patients whose cancer has progressed despite chemotherapy. It is possible that, if approved, necitumumab would be used as first-line treatment. Other companies marketing NSCLC drugs include Roche (Avastin, bevacizumab) and Bristol-Myers Squibb (Opdivo, nivolumab).

Sources: Reuters; May 9, 2015; and BioSpace; July 9, 2015.


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