(Reuters) – Immunomedics Inc said on Thursday the U.S. Food and Drug Administration declined to grant accelerated approval for its breast cancer treatment, sacituzumab.
The company said it will request a meeting with the agency and work closely with the health 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,” Immunomedics Chief Executive Officer Michael Pehl said.
(Reporting by Aakash Jagadeesh Babu in Bengaluru; Editing by Sandra Maler)
