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Priority Review for Supplemental Biologics License Application of Enfortumab Vedotin +...

The U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for priority review for enfortumab vedotin-ejfv (Padcev® ; Astellas/Seagen with pembrolizumab (Keytryuda® ( Merck & Co; Merck Sharp & Dohme/MSD) as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body.
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.

ESMO 2019: Sacituzumab Govitecan Achieves 29 Percent ORR in Advanced Urothelial...

Interim data from a 100-patient cohort of cisplatin-eligible patients participating in the TROPHY-U-01, an international, multi-center, open-label, phase II study, in patients with metastatic...

Polatuzumab Vedotin + Bendamustine and Rituxan Increased Complete Response Rates in...

Positive results from the randomized Phase II GO29365-study (NCT02257567) that compared polatuzumab vedotin (RG7596) in combination with bendamustine plus rituximab (Rituxan®; Genentech/Roche) against bendamustine plus...

Sacituzumab Govitecan Show Promising Results in Patients with Advanced Triple-negative Breast...

A clinical trial of an antibody-drug conjugate that combines the active portion of a chemotherapy drug with an antibody targeting a molecule expressed on...

Breakthrough Therapy Designation for Brentuximab Vedotin in CD30-expressing Mycosis Fungoides and...

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for brentuximab vedotin (Adcetris®; Seattle Genetics) for the treatment of patients with...

Sacituzumab Govitecan Receives Breakthrough Therapy Designation for Triple-negative Breast Cancer

The investigational antibody-drug conjugate, sacituzumab govitecan, also know as IMMU-132 (Immunomedics), has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA)...

Breakthrough Therapy Designation for Sacituzumab Govitecan in Triple-negative Breast Cancer

Sacituzumab govitecan, also known as IMMU-132, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients...

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