ALK Testing: An accurate and validated ALK assay is necessary for the selection of patients for treatment with XALKORI. Assessment for ALK-positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilized.Pregnancy: XALKORI may cause fetal harm when administered to a pregnant woman. Studies in animals have shown reproductive toxicity. There are no data in pregnant women using XALKORI. This medicinal product should not be used during pregnancy unless the clinical condition of the mother requires treatment. Pregnant women, or patients becoming pregnant while receiving XALKORI, or treated male patients as partners of a pregnant women, should be apprised of the potential hazard to the fetus. Adverse Reactions: Safety of XALKORI was evaluated in 386 patients with previously treated ALK-positive NSCLC in 2 single-arm clinical trials (Study 1001 and PROFILE 1005). The most common any-grade adverse reactions (>20%) across both studies were vision disorder, nausea, diarrhea, vomiting, edema, constipation, and fatigue. The most common Grade 3 or 4 adverse reactions (≥3%) across both studies were increased ALT and neutropenia.
- Vision disorder including diplopia, photopsia, vision blurred, visual impairment, and vitreous floaters was experienced by 76 (61%) patients in Study 1001 and 149 (57%) patients in PROFILE 1005. Ophthalmological evaluation should be considered if vision disorder persists or worsens in severity.
- Nausea, diarrhea, vomiting, and constipation were the most commonly reported gastrointestinal events, and were primarily Grade 1 in severity. Supportive care for gastrointestinal events may include standard antiemetic and/or antidiarrheal or laxative medicinal products.
- Neuropathy, primarily peripheral neuropathy, was experienced by 11 (9%) patients in Study 1001 and 33 (13%) patients in PROFILE 1005, and was primarily Grade 1 in severity. Dizziness and dysgeusia were also very commonly reported in these studies, but were all Grades 1 or 2 in severity.