Drug Development, Regulatory

FDA hands a ‘breakthrough’ designation to Seattle Genetics’ pivotal-stage cancer drug enfortumab

Seattle Genetics and their partners at Astellas got a boost from the FDA today for their quest to score an accelerated approval for enfortumab vedotin.

Steven Benner

The agency has stamped their breakthrough drug designation on the program, highlighting its potential as the drug makes its way through a pivotal Phase II study for metastatic urothelial cancer. That’s a welcome endorsement for Seattle Genetics $SGEN, which has tapped this drug as one of its top clinical prospects.

Last summer investigators highlighted promising early Phase I data, with 16 of 30 patients treated at the best dose scoring an objective response — that’s 53%, with one of those patients gaining a complete response with no visible signs of the cancer.

These were heavily pretreated patients, with 95% through chemo and almost half treated with a checkpoint inhibitor. In addition to the monotherapy study, the partners are also in the clinic with a checkpoint combo and trials involving ovarian and non-small cell lung cancer.

The drug is an antibody drug conjugate that targets nectin-4, which can be found on the surface of several solid tumors.

Breakthrough designations are no guarantees of success, but the oncology group in the FDA has achieved a rep for fast action with the drugs on their list, often offering quick OKs.

Steven Benner, the head of oncology R&D at Astellas, said:

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.


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