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FDA releases statement on the efficacy of Lartruvo®

April 12, 2019

On January 24, 2019, the U.S. Food and Drug Administration (FDA) released a statement regarding the efficacy of the drug Lartruvo® (olaratumab). Lartruvo® was approved by the FDA in October 2016, to treat soft tissue sarcoma, in combination with doxorubicin. A long-term clinical study has found that treatment with Lartruvo® and doxorubicin did not meet the primary endpoint of improvement in overall survival compared with a placebo and doxorubicin. Additionally, the National Comprehensive Cancer Network has removed the combination regimen of Lartruvo® and doxorubicin as a recommended therapy in their Soft Tissue Sarcoma guidelines.

Effective April 12, 2019, AmeriHealth will no longer consider Lartruvo® as medically necessary for treatment of soft tissue sarcoma in combination with doxorubicin. In accordance with the FDA statement, providers who are currently treating AmeriHealth members with Lartruvo® should speak with them about the feasibility of continued treatment with the drug. An AmeriHealth medical policy on Lartruvo® is currently in development.

For more information

The complete statement on Lartruvo® is available on the FDA website. If you have any questions about this update, please email us at providercommunications@amerihealth.com.


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