Astellas Pharma, Inc. and Seattle Genetics, Inc. were granted Breakthrough Therapy Designation by the FDA for enfortumab vedotin, an antibody-drug conjugate (ADC), for locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI).

Breakthrough Therapy Designation aims to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition and may offer substantial improvement over available therapy.

The Breakthrough Therapy Designation was granted based on interim results from the Phase I study examining enfortumab vedotin as monotherapy treatment for patients with metastatic urothelial cancer who were previously treated with CPIs. Enfortumab vedotin is being studied in a pivotal clinical trial, EV-201 (NCT03219333), as monotherapy in this patient setting and in an early-phase clinical trial in combination with CPI therapy, EV-103 (NCT03288545). The companies are also evaluating enfortumab vedotin in other solid tumors, including ovarian and non-small cell lung carcinoma.
 
“The FDA Breakthrough Therapy Designation underscores the potential of enfortumab vedotin as a meaningful treatment for patients with locally advanced or metastatic urothelial cancer. Further, it supports our rapid development plans for this ADC, including the ongoing pivotal study in this patient population,” said Robert Lechleider, M.D., vice president, Clinical Development at Seattle Genetics.

“Achieving Breakthrough Therapy Designation for enfortumab vedotin is another step forward in our goal to bring an additional treatment option to patients who need it most,” said Steven Benner, M.D., senior vice president and Global Therapeutic Area Head, Oncology Development at Astellas. “With the enfortumab vedotin registrational Phase II trial and CPI-combination trial actively underway, Astellas looks forward to expanding development of enfortumab vedotin and its oncology pipeline, including treatments that would target some of the hardest-to-treat cancers.”