Drug Safety Warning: Xalkori-Related Ocular Toxicity and Severe Visual Loss are Difficult to Detect in Children
Xalkori (crizotinib) is approved by the FDA for the treatment of:
- Patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test; and,
- Pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.
While reviewing a June 14, 2022, European Pharmaceutical Review (EPR) article about the most recent meeting of EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), we learned of a new drug safety issue involving Xalkori-related vision disorders found in clinical trials for pediatric patients treated with Xalkori.
In relevant part from this EPR article about the EMA’s PRAC June meeting highlights:
Xalkori has been studied in children from six to 18 years of age as a monotherapy for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK positive or patients with unresectable, recurrent, or refractory ALK positive inflammatory myofibroblastic tumour (IMT).
Vision disorders have been reported in 61 percent of paediatric patients treated with [Xalkori (crizotinib)] in clinical trials for these indications.
Vision disorders and ocular toxicity are more challenging to detect in children. Paediatric patients should be monitored for ocular toxicity, including the risk of severe vision loss. They should receive a baseline ophthalmologic examination prior to starting Xalkori with follow-up examinations. Healthcare professionals are advised to inform patients and caregivers of the symptoms and remind them to contact their doctor if any of these symptoms develop. Any visual symptoms should be referred to an eye specialist.
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To date, we have not seen any similar FDA warning about this new drug safety issue involving Xalkori-related vision disorders for children. We point out there were some revisions made in January 2021 to the "5.5 Severe Visual Loss" part of the WARNINGS AND PRECAUTIONS section in the Xalkori Prescribing Information document, but this pertained to patients generally, not pediatric patients only.
We will continue to monitor the drug regulatory sector as well as the medical literature for further developments concerning ocular toxicity and severe visual loss in children treated with Xalkori.
If you have any relevant information about Xalkori-related vision disorders in pediatric patients, please feel free to share by posting a Comment below or, if you prefer, contacting me directly.
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