Immunomedics receives FDA complete response letter

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/David Hagerman)
(Image: Getty/David Hagerman)

Related tags: Fda, Biologics, Clinical data, Manufacturing

Immunomedics received a complete response letter from the US FDA for its BLA seeking approval of its biologic, sacituzumab govitecan.

The biologic is a candidate for the treatment of patients with metastatic triple-negative breast cancer who have received at least two prior therapies. The biologics license application (BLA) of this candidate was seeking accelerated approval.

“We believe in sacituzumab govitecan’s potential to be a viable treatment option for these patients,”​ said Michael Pehl, president and CEO of Immunomedics, in a statement.

Immunomedics said that the issues mentioned in the CRL are related to chemistry, manufacturing, and control matters, as a result, no new clinical or preclinical data needs to be generated.

Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products. The company would not disclose any further information at this time.

After receiving the CRL, Immunomedics’ share prices dropped 35% premarket.

Previous challenges

This is not the first difficulty​ Immunomedics has faced bringing drug candidates to market. In 2013, Takeda terminated a partnership with Immunomedics after delays in the development of the agreed upon monoclonal antibody – veltuzumab.

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