Bristol-Myers Squibb's Opdivo cleared for once every four-week dosing by FDA

Bristol-Myers Squibb on Tuesday announced that the FDA approved an application to update the dosing schedule of Opdivo (nivolumab) to once every four weeks for a majority of approved indications. The drugmaker noted that the therapy is the first PD-1 inhibitor to receive clearance for such a dosing schedule, having previously been dosed every two weeks. Johanna Mercier, head of Bristol-Myers Squibb's US commercial operations, stated "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." 

According to the drugmaker, the new dosing schedule was cleared for use in patients with metastatic melanoma, either as monotherapy or monotherapy phase after combination treatment with Yervoy (ipilimumab), 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. 

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The regimen was also authorised for the treatment of certain patients with classical Hodgkin lymphoma, recurrent/metastatic squamous cell carcinoma of the head and neck and hepatocellular carcinoma, in addition to use as adjuvant therapy for patients with completely resected melanoma with lymph node involvement or metastatic disease. 

Bristol-Myers Squibb noted that Opdivo was also cleared for use as a shorter 30-minute infusion across all approved indications. The drugmaker added that dosing schedule updates for an additional approved indication may be submitted to the FDA in the future. 

Opdivo was initially awarded accelerated approval by the FDA in 2014 for use in patients with unresectable or metastatic melanoma who no longer respond to other treatments. Its indication was later expanded to cover several cancer types, including previously untreated BRAF V600 wild-type unresectable or metastatic melanoma

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