FDA grants accelerated approval to Lilly's soft tissue sarcoma drug

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo

(Reuters) - The U.S. Food and Drug Administration on Wednesday granted accelerated approval to Eli Lilly and Co’s drug for treating adults with advanced soft tissue sarcoma (STS).

Lilly's drug, Lartruvo, is approved for use with FDA-approved chemotherapy doxorubicin in STS patients who cannot be cured with radiation or surgery or who have a type of STS for which chemotherapeutic agent anthracycline is an appropriate treatment. (

Soft tissue sarcoma refers to cancers that develop in muscles, fat, tendons or other soft tissues.

The National Cancer Institute estimates that 12,310 new cases of STS and nearly 5,000 related deaths are likely to occur in 2016.

The European Medicines Agency last month recommended conditional marketing approval for the drug in combination with doxorubicin in the European Union.

Lartruvo has already been granted orphan drug status and breakthrough therapy status by the U.S. health regulator.

Indianapolis, Indiana-based Lilly’s shares were up marginally in afternoon trading.

Reporting by Akankshita Mukhopadhyay and Dipika Jain in Bengaluru; Editing by Maju Samuel