FDA: Lilly’s Necitumumab Bolsters Survival, but Raises Sudden Death Risk
Eli Lilly’s lung cancer drug necitumumab improved overall survival when used with two combined chemotherapies, but caused a small uptick in sudden deaths, the FDA says in a preliminary review.
In a clinical trial, patients administered necitumumab in combination with gemcitabine and cisplatin saw their median overall survival reach 11.5 months, 1.6 months longer than those receiving gemcitabine and cisplatin alone.
However, 48 percent of patients in the necitumumab arm of the study experienced serious side effects, compared with 38 percent in the control group. Drug-related deaths were reported in 15 of 66 deceased patients in the necitumumab group and 10 of 57 in the control arm.
The Oncologic Drugs Advisory Committee met last week to recommend whether the drug should be approved for use in first-line treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer.
The risk of fatal heart attack or sudden death was 2.2 percent among patients receiving all three drugs, compared with 0.5 percent in those taking just gemcitabine and cisplatin. The cause of death in these patients is unclear, but may be due to electrolyte disturbances associated with both necitumumab and platinum therapy, the FDA says.
The clinical trial, completed in 2013, offered Lilly good news in its development of necitumumab as a cancer treatment. The company stopped accepting patients for a separate study involving advanced nonsquamous non-small cell lung cancer after 31 patients developed blood clots.
Read the briefing document here: www.fdanews.com/7-15-FDA-Necitumumab.pdf. — Jonathon Shacat