Immunomedics Receives Complete Response Letter From FDA for Sacituzumab Govitecan Biologics License Application

- January 18th, 2019

Immunomedics (NASDAQ:IMMU) a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received … Continued

Immunomedics (NASDAQ:IMMU) a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.

As quoted in the press release:

“We believe in sacituzumab govitecan’s potential to be a viable treatment option for these patients,” said Michael Pehl, President and Chief Executive Officer of Immunomedics. “The issues related to approvability in the CRL were exclusively focused on Chemistry, Manufacturing and Control matters and no new clinical or preclinical data need to be generated. We are going to request a meeting with the FDA as soon as possible to gain a full understanding of the Agency’s requirements and timelines for approval and we will work closely with the FDA with the goal of bringing this important medicine to patients as soon as possible.”

Click here to read the full press release.

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