Monday, August 28, 2017

Going Off-Label - Cancer Today

Physicians are legally permitted to prescribe drugs approved for one purpose to be used for another, a practice called off-label prescribing. The rise of targeted therapies and immunotherapies is creating new challenges for navigating off-label options.



By Kate Yandell


When Tori Tomalia’s oncologist gave her a new prescription for pills to treat her stage IV non–small cell lung cancer (NSCLC) in November 2013, she expected it would be filled routinely. Instead, the pharmacist told the 37-year-old that her insurance company had declined to cover the prescription and that she would need prior authorization for the medication.
Exploring Trials
Clinical trials are testing off-label use in patient with advanced cancers who have exhausted standard treatments.

Assessing Therapies
Know what tips to follow when considering off-label drug use with your physician.
Her new therapy, Xalkori (crizotinib), had been approved by the U.S. Food and Drug Administration (FDA) in 2011 to treat advanced NSCLC patients with ALK gene mutations in their tumors. Tomalia, a mother of three and the owner of a brewery and theater in Ann Arbor, Michigan, instead had learned her cancer had a mutation in the gene ROS1. Clinical trial data had indicated that patients like Tomalia whose cancers had the ROS1 mutation did well on Xalkori, so her oncologist prescribed it. This practice, called off-label treatment, is legal and common in medicine. 



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