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FDA Accepts Applications for Nivolumab Four Week Dosing Schedule Across All Approved Indications

Supplemental Biologics License Applications to update nivolumab dosing
10 Aug 2017
Cancer Immunology and Immunotherapy

On 24 July 2017, Bristol-Myers Squibb Company announced that the US Food and Drug Administration (FDA) accepted its supplemental Biologics License Applications (sBLAs) to update nivolumab(Opdivo) dosing to include 480 mg infused over 30 minutes every four weeks (Q4w) for all currently approved monotherapy indications.

Filing for four week dosing infused over 30 minutes across approved nivolumab monotherapy indications supports innovation and making cancer treatment more convenient for healthcare providers, caregivers and patients.

The applications are under review with an action date of 5 March, 2018.

Bristol-Myers Squibb is enhancing the scientific understanding of onco-immunology through extensive portfolio of investigational compounds and approved agents. Their clinical development programme is studying broad patient populations across more than 50 types of cancers with 14 clinical-stage molecules designed to target different immune system pathways. Expertise and innovative clinical trial designs are focused to advance the combination therapies of onco-immunology drugs with other cancer immunotherapeutics, or with chemotherapy, targeted therapies and radiation therapy across multiple tumours. They also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how a patient’s tumour biology can be used as a guide for treatment decisions.

They understand making the promise of onco-immunology a reality for the many patients who may benefit from these therapies requires not only innovation on pharma part but also close collaboration with leading experts in the field through partnerships with academia, government, advocacy and biotech companies.

Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor which global development programme includes a broad range of clinical trials across all phases, including phase III, in a variety of tumour types. To date, the nivolumab clinical development programme has enrolled more than 25,000 patients. The nivolumab trials have contributed to gaining a deeper understanding of the potential role of biomarkers, particularly regarding how patients may benefit from nivolumab across the continuum of PD-L1 expression.

In July 2014, nivolumab was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. It is currently approved in more than 60 countries. In October 2015, the nivolumab and ipilimumab combination regimen was the first onco-immunology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries.

The Bristol-Myers Squibb’s press release contains forward-looking statements.

Last update: 10 Aug 2017

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