Bristol-Myers Squibb Nabs Two Key Approvals

Apr 28, 2017

Bristol-Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) as monotherapy for the treatment of squamous cell cancer of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy. Opdivo is the first and only Immuno-Oncology (I-O) treatment that demonstrated in a Phase 3 trial a significant improvement in overall survival (OS) for these patients.

The approval was based on results from CheckMate -141, a global Phase 3, open-label, randomized trial, first published in The New England Journal of Medicine last October, which evaluated Opdivo versus investigator’s choice of therapy in patients aged 18 years and above with recurrent or metastatic, platinum-refractory SCCHN who had tumor progression during or within six months of receiving platinum-based therapy administered in the adjuvant, neo-adjuvant, primary or metastatic setting.

“The European Commission’s approval of Opdivo marks not only the first new treatment option in 10 years for patients with advanced cancers of the head and neck, but also the first Immuno-Oncology treatment for SCCHN,” said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb. “Bristol-Myers Squibb remains committed to redefining survival for patients with cancer, and now that Opdivo is approved in Europe, we will work collaboratively with EU health authorities to ensure it is available for these patients as quickly as possible.”

In other company news, BMS also announced that the China Food and Drug Administration (CFDA) has approved a direct-acting antiviral regimen comprised of Daklinza (daclatasvir) and Sunvepra (asunaprevir), for the treatment of treatment-naive or -experienced patients, with or without compensated cirrhosis, infected with genotype 1b chronic hepatitis C virus (HCV).

This is China’s first all-oral, interferon- and ribavirin-free HCV treatment regimen. Also, Daklinza has been approved in China for combination use with other agents, including sofosbuvir, for adult patients with HCV genotypes 1-6 infection. This is the only all-oral pan-genotypic regimen recommended by China’s HCV Prevention and Treatment Guideline. Daklinza must not be administered as monotherapy. Sofosbuvir is under review by the CFDA, and is not currently licensed in China.

In more than 60 countries, Daklinza is approved as part of a regimen with either Sunvepra or sofosbuvir. In China, Daklinza-based regimens provide a shorter treatment duration (12 or 24 weeks) compared to 48 weeks of treatment with previously approved regimens. The Daklinza and Sunvepra regimen is already approved by regulatory authorities in multiple countries across the Asia Pacific, Latin America, and Eastern Europe regions. Sunvepra is not approved in the United States.

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