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Bristol-Myers: Opdivo The Only FDA-approved PD-1 Inhibitor With 4-week Dosing

Bristol-Myers Squibb Co. (BMY) said that the U.S. Food and Drug Administration or FDA has approved a supplemental Biologics License Application or sBLA updating the Opdivo, or nivolumab dosing schedule to include 480 mg infused every four weeks (Q4W) for a majority of approved indications.

According to the company, Opdivo is now the first and only FDA-approved PD-1 inhibitor to offer every four-week dosing.

Bristol-Myers noted that the approval will provide health care professionals the flexibility to customize patient care with the option of using the newly approved Q4W (480 mg) flat dose in addition to the previously available option of every two weeks (Q2W) at 240 mg, now available in a new 240 mg vial.

Opdivo also was approved for a shorter 30-minute infusion across all approved indications, cutting the previous infusion time in half. Bristol-Myers said that dosing schedule updates for an additional approved indication for Opdivo may be submitted to the FDA in the future.

"From the introduction of our first Immuno-Oncology agent through today's approval of flexible dosing options at two- or four-week intervals, we are relentless in pursuing innovative options for the cancer community. With this approval, we now offer the most robust range of dosing options for an Immuno-Oncology medicine, providing enhanced flexibility to help address each patient's specific needs," Johanna Mercier, head, U.S. Commercial, Bristol-Myers Squibb, said.

The Q4W (480 mg) flat dose option is approved for metastatic melanoma, previously treated metastatic non-small cell lung cancer, advanced renal cell carcinoma following prior anti-angiogenic therapy, and previously treated locally advanced or metastatic urothelial carcinoma following disease progression during or after platinum-based chemotherapy.

In addition, the flat dose option is approved for classical Hodgkin lymphoma following relapse/progression after autologous hematopoietic stem cell transplantation or HSCT and brentuximab vedotin, or three or more lines of systemic therapy that includes autologous HSCT; recurrent/metastatic squamous cell carcinoma of the head and neck following platinum-based therapy, hepatocellular carcinoma after prior sorafenib therapy, and adjuvant therapy for patients with completely resected melanoma with lymph node involvement or metastatic disease.

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