FDA Grants Breakthrough Therapy Status to BMS’ Opdivo for Bladder Cancer

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Bristol-Myers Squibb’s Opdivo (nivolumab) for advanced bladder cancer. Specifically the FDA granted breakthrough therapy status for Opdivo for treating unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-containing regimen. <.p>

The breakthrough therapy designation is an FDA program intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases to help ensure patients have access to new therapies as soon as possible. According to the FDA, the criteria for a breakthrough therapy designation requires preliminary clinical evidence that demonstrates the medicine may have substantial improvement on at least one clinically significant endpoint over available therapy.

Previous breakthrough therapy designations granted for Opdivo by the FDA include previously treated recurrent or metastatic squamous cell carcinoma of the head and neck, Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab-vedotin, previously treated advanced melanoma, previously treated non-squamous non-small cell lung cancer, and previously treated advanced or metastatic renal cell carcinoma.

Opdivo is now approved in the US for several cancer indications. It is approved as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. It is also approved as a single agent for treating patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. It is also approved in combination with Bristol-Myers Squibb’s Yervoy (ipilimumab) for the treatment of patients with unresectable or metastatic melanoma.

Opdivo is alos approved for treating patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. It is approved for treating patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. And it is also prooved for treating patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post- transplantation brentuximab vedotin.

Source: Bristol-Myers Squibb

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