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    Immunomedics BLA resubmission for sacituzumab govitecan to treat breast cancer accepted by USFDA

    Farhat NasimWritten by Farhat Nasim Published On 2019-12-28T09:10:06+05:30  |  Updated On 28 Dec 2019 9:10 AM IST

    Sacituzumab govitecan has been awarded both Fast Track Designation and Breakthrough Therapy Designation by the USFDA, Immunomedics said in its recent release.


    New Delhi: Immunomedics, a biopharmaceutical company in the area of antibody-drug conjugates, announced that the US Food and Drug Administration (FDA) has accepted for filing the company's 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 a complete class 2 response. The PDUFA target action date of the resubmitted BLA is June 2, 2020.


    We are pleased that the FDA has accepted our resubmission, which was a top priority for us in 2019, said Dr. Behzad Aghazadeh, executive chairman of Immunomedics. We look forward to working closely with the FDA to facilitate their review of our BLA to enable us to bring this potentially transformational treatment to patients affected by mTNBC.


    Sacituzumab govitecan has been awarded both Fast Track Designation and Breakthrough Therapy Designation by the FDA.


    TNBC is an aggressive disease with an annual incidence estimated to be about 40,000 people, approximately 15% of all breast cancer types, in the United States alone. The incidence rate is higher among younger women and highest among non-Hispanic black and Hispanic women. TNBC tumours do not have sufficient estrogen, progesterone or HER2 receptor expression to indicate the use of hormonal or HER2-directed therapy. There is currently no standard-of-care chemotherapy for people with relapsed/refractory mTNBC. An overall response rate of about 10% and median progression-free survival of 2-3 months have recently been reported in late-stage mTNBC using single-agent chemotherapy.


    Also Read: AstraZeneca-Daiichi breast cancer drug Enhertu gets speedy USFDA nod

    Biologics License ApplicationBLAbreast cancerFDAimmunomedicsmetastatic triple-negative breast cancermTNBCsacituzumab govitecanUSFDA

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    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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