FDA approves sBLA for Opdivo updating dosing schedule. - BMS

Bristol-Myers Squibb Company announced the FDA has approved a supplemental Biologics License Application (sBLA) updating the Opdivo (nivolumab) dosing schedule to include 480 mg infused every four weeks (Q4W) for a majority of approved indications. This 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. Dosing schedule updates for an additional approved indication for Opdivo may be submitted to the FDA in the future.

The Q4W (480 mg) flat dose option is approved for the following indications for Opdivo: � Metastatic melanoma (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. � Previously treated locally advanced or metastatic urothelial carcinoma following disease progression during or after platinum-based chemotherapy. � Classical Hodgkin lymphoma following relapse/progression after autologous hematopoietic stem cell transplantation (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. � Adjuvant therapy for patients with completely resected melanoma with lymph node involvement or metastatic disease.