A monoclonal antibody that targets epidermal growth factor receptor.
Approved for use in combination with two forms of chemotherapy, gemcitabine and cisplatin in patients with metastatic NSCLC.
The median OS was 11.5 months, compared with 9.9 months on the doublet of gemcitabine and cisplatin.
Approved for use only in squamous NSCLC, which constitutes about a third of all lung cancers.
Not active in nonsquamous NSCLC.
Most common side effects are skin rash and magnesium deficiency, which can cause muscular weakness, seizure, irregular heartbeats, and can be fatal.
Serious risks of treatment with necitumumab, including cardiac arrest and sudden death, in addition to hypomagnesemia.
Portrazza™ (necitumumab)
In combination with gemcitabine and cisplatin, is the first FDA-approved biologic for the first-line treatment of patients with metastatic squamous NSCLC.
Squire Trial a multicenter, phase III trial in 1093 patients
Not indicated for the treatment of nonsquamous NSCLC.
Cardiopulmonary arrest and/or sudden death occurred in 3% of patients treated with necitumumab in combination with gemcitabine and cisplatin.
Closely monitoring serum electrolytes, including serum magnesium, potassium, and calcium, with aggressive replacement when warranted I’d required.
Hypomagnesemia occurs in 83% of patients receiving necitumumab in combination with gemcitabine and cisplatin, and was severe in 20% of patients.
Monitor patients for hypomagnesemia, hypocalcemia, and hypokalemia prior to each dose of necitumumab during treatment and for at least 8 weeks following completion of necitumumab.
Withhold necitumumab for grade 3 or 4 electrolyte abnormalities.
Hypomagnesemia occurred in 83% of patients treated with necitumumab as compared to 70% of patients with available treated with gemcitabine and cisplatin alone in the study.
Hypomagnesemia was severe in 20% of the patients treated with necitumumab compared to 7% of the patients treated with gemcitabine and cisplatin alone.
The median time to development of hypomagnesemia and accompanying electrolyte abnormalities was 6 weeks.
Venous and arterial thromboembolic events some fatal, were observed with necitumumab in combination with gemcitabine and cisplatin.
The incidence of VTE was 9% in patients receiving necitumumab plus gemcitabine and cisplatin versus 5% in patients receiving gemcitabine and cisplatin alone, and the incidence of grade 3 or higher VTEs was 5% versus 3%, respectively.
Necitumumab should be discontinued for patients with serious or life-threatening VTE or arterial thromboembolic disease.
Dermatologic toxicities, including rash, dermatitis acneiform, acne, dry skin, pruritus, generalized rash, skin fissures, maculo-papular rash, and erythema, occurred in 79% of patients receiving necitumumab
Skin toxicity is severe in 8% of patients, and develops within the first 2 weeks of therapy and resolved within 17 weeks after onset.
Most infusion related reactions occur after the first or second administration
Not indicated for the treatment of patients with nonsquamous NSCLC, as patients experience more serious and fatal toxicities and cardiopulmonary arrest/sudden deaths within 30 days of the last study drug.
Can cause fetal harm when administered to a pregnant woman.
Associated with risk of rash, acne, pruritus, dry skin, skin fissures, vomiting, diarrhea, stomatitis, weight loss, hemoptysis, pulmonary embolism, headache, VTE, paronychia, and conjunctivitis.
The most common severe adverse events that occurred at a ≥2% higher rate.
Electrolyte abnormalities: include hypomagnesemia, hypokalemia, hypocalcemia and hypophosphatemia.
The median time to onset of hypomagnesemia was 6 weeks, and resolved in 43% of the patients.
Can cause fetal harm when administered to a pregnant female.
Cardiopulmonary arrest or sudden death occurred in 3% of 538 patients treated with Portrazza plus gemcitabine and cisplatin as compared to 0.6%) of patients treated with gemcitabine and cisplatin alone in study.