1. Scrip
  2. >>Therapy Areas

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.

Doctor with Mammography - Image
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. 

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Anticancer

More from Therapy Areas

Ironwood To Consider All Options With Apraglutide Setback In SBS

 
• By Joseph Haas

With the FDA asking for another Phase III trial, the short bowel syndrome drug apraglutide could be years away from market, while the Linzess patent expiry and near-term debt loom.

Pfizer’s Danuglipron Is Done, Sparking M&A Speculation

 
• By Jessica Merrill

The company discontinued development of its oral GLP-1 receptor agonist for weight management due to a safety signal.

Amgen’s Imdelltra Sets The Pace In Small-Cell Lung Cancer

 
• By Andrew McConaghie

The bispecific is the first in its class to record a Phase III survival win in small-cell lung cancer, although antibody-drug conjugates and other rivals could challenge in the coming years.