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Setback For Athenex, Hanmi As CRL Requests New Trial

Another US Delay For Korean Firm's Assets

 
• By Jung Won Shin

Hanmi partner Athenex has had a US complete response letter for its oral paclitaxel plus encequidar product for the treatment of metastatic breast cancer, amid concerns of safety risks associated with an increase in neutropenia-related sequelae. While the decision marks another setback for Hanmi in the US, Athenex is aiming to resolve the issues.

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Should Conduct New Adequate Clinical Trial • Source: Shutterstock

The US Food and Drug Administration's (FDA) issuance of a complete response letter (CRL) on Athenex, Inc.’s new drug application for its oral paclitaxel plus encequidar product for metastatic breast cancer is disappointing, not only for the US firm but also its licensor, South Korea's Hanmi Pharmaceutical Co., Ltd., which will see an approval delay for another of its product candidates. 

In the CRL decision, the FDA indicated its concern of a safety risk to patients in terms of an increase in neutropenia-related sequelae on the oral paclitaxel arm compared with...

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