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Immunomedics sacituzumab fails to win accelerated approval from the FDA


Immunomedics sacituzumab fails to win accelerated approval from the FDA

“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. 

New Delhi: Immunomedics Inc recently said that 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.

Also Read: FDA declines to approve Akcea-Ionis genetic disease drug

“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.

Immunomedics is a pharmaceutical company focusing on the development of antibody-drug conjugates for the treatment of cancer.

Also Read: FDA declines to approve Insys Therapeutic’s opioid painkiller



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