By Ann Miller Baker - October 25, 2018
Flu season can be a frightening time for patients whose immune systems are weakened from battling cancer. So headlines about a new single-dose antiviral flu treatment have many wondering – could this help cancer patients who develop the flu?
The U.S. Food and Drug Administration says Xofluza (baloxavir marboxil) is safe and effective for those 12 years of age and older when used within 48 hours of their first flu symptoms. But Moffitt Cancer Center experts advise caution – especially until this newly developed drug is shown to be safe for an immunosuppressed patient population.
“Based the currently available clinical trial data, Tamiflu (oseltamivir) and Xofluza appear to be equally effective,” said Dr. Rod Quilitz, supervisor of Clinical Pharmacy Support Services at Moffitt. “In an abundance of caution, it has been our practice to defer evaluating new antimicrobial drugs for at least six months unless they clearly represent a clinical advance over current therapy.”
This “wait and see” approach provides time to monitor reported patient experiences in a broader population before advising whether or not any new antimicrobial drug is appropriate for Moffitt patients, given their specific immune issues.
Randomized clinical trials that led to FDA approval were conducted in both the U.S. and Japan among otherwise healthy study participants. A companion study among patients at high risk of complications from the flu was conducted during last year’s flu season, but those results have not yet been formally presented. Further studies among hospitalized influenza patients are planned.
Cost is another consideration. Generic forms of Tamiflu are currently available for $50, a fraction of the $150 anticipated wholesale cost of Xofluza.
The new drug is a welcome new weapon against the flu, FDA Commissioner Dr. Scott Gottlieb said in a news release. “This is the first new antiviral flu treatment with a novel mechanism of action to gain FDA approval in nearly 20 years. With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical.”
But Gottlieb stressed that antivirals are not a substitute for yearly vaccinations. “Seasonal flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can result in hospitalizations,” he said. “Yearly vaccination is the primary means of preventing and controlling flu outbreaks.”
Read more about flu vaccination and cancer patients here.