Immunomedics, Inc: sacituzumab govitecan

1. Reference is made to the pre-license inspection at Immunomedics Inc. (Morris Plains, NJ) and subsequent communications between Immunomedics and the Agency:

October 3, 2018 and December 14, 2018, and nn iple communications thr teleconferences with the agenc:

To facilitate review of labeling, provide a highlighted or marked-up copy that shows all changes, as well as a clean Word version, at the time of the resubmission.

During a recent inspection of the Immunomedics, Inc., (FEI 1000526871) manufacturing facility for this BLA, our field investigator observed objectionable conditions at the facility and conveyed that information to the representative of the facility at the close of the inspection.

1. Reference is made to the information and data provided in response to the agency's information requests (IRs) dated November 13, 2018 and January 5, 2019, concerning the qualification of the hRS7 and IMMU-132 reference standards.

To support this labelmg, im your resubmission, provide a new full BICR evaluation of ORR for the entire efficacy population, based upon the data cutoff date in origmal BLA submission (June 30, 2017), and provide duration of response based upon the origmal data cutoff date and the extended follow-up data cutoff date (December 1, 2017).

If you do not take one of these actions, we may consider your lack of response a request to withdraw the application under 21 CFR 601.3(c).

Between the FDA and Sponsors or Applicants of PDUFA Products," December 2017 at: