FDA OKs New Cancer Indication for BMS’ Opdivo

The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of patients with classical Hodgkin lymphoma who have relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin.

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

This is the fourth cancer indication for Opdivo, Bristol-Myers Squibb’s immune checkpoint inhibitor. It is approved to treat unresectable or metastatic melanoma: as a single agent for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma and as a single agent for the treatment of 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.

The drug is also approved to treat patients with metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy and for treating patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.

Opdivo is positioned as a potential blockbuster drug. In 2015, it posted sales of $942 million. A recent Thomson Reuters analysis projects 2019 sales of nearly $8.9 billion.

Source: Bristol-Myers Squibb

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