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FDA Clears IND Application for a Phase 1/2 Study of OBI-992...

The U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for OBI-992 (also known as BSI-992), to conduct a...

ESMO 2023: ADCs Taking Center Stage

During the annual ESMO 2023 Congress, organized by the European Society for Medical Oncology, held October 20 - 24, 2023 in Madrid, Spain, antibody-drug conjugates or ADCs took center stage, with presentations demonstrating the potential these ADCs show in the rapidly changing treatment landscape for various cancers.

Gilead Agrees to Collaborate on the Strata Precision Indications for Approved...

Gilead Sciences and Strata Oncology have signed an agreement in which Gilead has agreed to collaborate on the Strata Precision Indications for Approved THerapies (Strata PATH™; NCT05097599) study by providing sacituzumab govitecan-hziy (Trodelvy®) for eligible patients with cancer.
Featured Image: Women and the power to fight breast cancer Courtesy: © 2017. Fotolia. Used with permission.

FDA Accepts for Priority Review of sBLA for Gilead’s Sacituzumab Govitecan...

The U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for sacituzumab govitecan-hziy (Trodelvy®; Gilead Sciences)...
General images of ESMO 2019 Congress being held in Barcelona, Spain, September 27 - October 1, 2019. Courtesy European Society for Medical Oncology (ESMO). Used with Permission.

What to Expect at ESMO 2022: Sacituzumab Govitecan Show PFS Benefits...

New data from a post hoc subgroup analysis from the Phase 3 TROPiCS-02 study evaluating sacituzumab govitecan-hziy* (Trodelvy®, Gilead Sciences) versus comparator chemotherapies (physicians’...

Sacituzumab Govitecan Approved in China for Second-Line Metastatic Triple-Negative Breast Cancer

China's National Medical Products Administration (NMPA) has approved sacituzumab govitecan (Trodelvy®; Gilead Sciences) for the treatment of adult patients with unresectable locally advanced or metastatic...

Sacituzumab Govitecan Increases PFS for Patients With Most Common Type of...

Treatment with sacituzumab govitecan (Trodelvy®; Gilead Sciences), an antibody-drug conjugate (ADC), resulted in longer progression-free survival (PFS) compared to physician’s choice of chemotherapy in...

Sacituzumab Govitecan Receives European Marketing Authorization for the Treatment of mTNBC...

The European Commission (EC) has granted marketing authorization for sacituzumab govitecan (Trodelvy®; Gilead Sciences) a first-in-class topoisomerase inhibitor antibody-drug conjugate (ADC) directed to the...

Shanghai Fudan-Zhangjiang’s FDA018-ADC Enters Phase I Clinical Trials

The National Medical Products Administration of the People's Republic of China has accepted Shanghai Fudan-Zhangjiang Bio-Pharmaceutical’s request to allow FDA018-ADC to enter in phase...

Sacituzumab Govitecan Receives Accelerated Approval for Advanced or Metastatic Urothelial Cancer...

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Gilead Sciences* Sacituzumab Govitecan** (Trodelvy®) for use in adult patients with locally...

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