Immunomedics\' cancer treatment fails to win accelerated approval from the FDA

Immunomedics' cancer treatment fails to win accelerated approval from the FDA

Reuters 

(Reuters) - Inc said on Thursday the U.S. declined to grant for its treatment, sacituzumab.

The company said it will request a meeting with the agency and work closely with the regulator in its effort to launch the treatment as soon as possible.

"The issues related to approvability in the CRL (complete response letter) were exclusively focused on Chemistry, Manufacturing and Control matters and no new clinical or preclinical data need to be generated," said.

(Reporting by in Bengaluru; Editing by Sandra Maler)

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First Published: Fri, January 18 2019. 10:39 IST