FDA Expands Bristol-Myers Squibb’s Opdivo Dosing Schedule

The U.S. Food and Drug Administration (FDA) expanded the dosing schedule for Bristol-Myers Squibb Company’s Opdivo (nivolumab). It granted a supplemental Biologics License Application (sBLA) to include a 480 mg infusion every four weeks for a majority of indications. It is currently approved for every two weeks at 240 mg and for a shorter 30-minute infusion.

The new dose option has been approved for: metastatic melanoma (monotherapy or monotherapy phase after combination treatment with Yervoy (ipilimumab); previously treated metastatic non-small cell lung cancer (NSCLC); advanced renal cell carcinoma after previous anti-angiogenic therapy; previously treated locally advanced or metastatic urothelial carcinoma after disease progression during or after platinum-based chemotherapy; classical Hodgkin lymphoma after relapse/progression following 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 after platinum-based therapy; hepatocellular carcinoma after prior sorafenib therapy; adjuvant therapy for patients with completely resected melanoma with lymph node involvement or metastatic disease.

"At Bristol-Myers Squibb, we are united in our mission to fight cancer from all angles and recognize every patient has unique needs," said Johanna Mercier, head, U.S. Commercial, Bristol-Myers Squibb, in a statement. "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."

In other news, Bristol-Myers Squibb was named one of the Top Companies for Executive Women for 2018 by the National Association for Female Executives. The company has landed on the list for the last 15 years. And, in fact, because it hit the list for 15 years, it is a Hall of Fame company on the list.

Companies were chosen based on a set of criteria that included a minimum of two women on their board of directors as well as at least 1,000 U.S. employees. The application included more than 200 questions on topics that included female representation at all levels, but especially the corporate officer and profit-and-loss leadership ranks. It also took into account how many employees have access to programs and policies that promote advancement of women and how many people take advantage of them.

The company was noted for recent enhancements to this U.S. Family Care Leave, which provides generous paid leave to employees, and noted that Bristol-Myers Squibb Network of Women were promoted 2.5 times more frequently, and in surveys, indicated a strong desire to stay with the company.

"Bristol-Myers Squibb prioritizes a diverse workplace, including female representation and advancement, to ensure the company is well positioned to meet current and future business challenges," the company stated, regarding the award. "The company cultivates and supports female employees and executives with a number of initiatives and policies. In 2017, female employees and female promotions represented more than 50 percent of the Bristol-Myers Squibb workforce. Women are supported through targeted development, coaching, mentoring and sponsorship programs to help accelerate their career progression."

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