FDA Awards BMS’ Opdivo Breakthrough Therapy Designation

The FDA awarded Bristol-Myers Squibb’s Opdivo a breakthrough therapy designation for metastatic renal cell carcinoma, adding another potential indication to the growing list for the PD-1 inhibitor.

The designation entitles the company to more frequent meetings with the FDA in an effort to speed up the review process to make the drug available to patients more quickly.

The decision follows a successful Phase 3 study that was cut short after Opdivo met the primary endpoint and showed superior overall survival compared to the current standard of care for advanced kidney cancer.

Though serious reactions were reported in 59 percent of the kidney cancer patients in the Phase 3 trial, BMS hopes Opdivo will put a dent in the 12.1 percent five-year survival rate for patients with advanced RCC.

The company will present full study results at the European Cancer Congress later this month; it plans to submit data to regulatory agencies this year.

The FDA approved Opdivo last December for previously treated advanced melanoma, and it was approved in March for second-line treatment for metastatic squamous non-small cell lung cancer that progressed after chemotherapy. The FDA is considering the drug’s sBLA for previously untreated advanced melanoma with a Nov. 27 PDUFA date.

BMS earlier cut short the comparator arm in an Opdivo study in advanced nonsquamous non-small cell lung cancer when data showed a survival benefit over chemotherapy.

Opdivo blocks a protein that keeps the immune system from identifying and attacking cancer cells. — Victoria Pelham