Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 15 September 2016 | By Zachary Brennan
The US Food and Drug Administration (FDA) has agreed to modify the dosage regimen for Bristol-Myers Squibb’s cancer treatment Opdivo (nivolumab) for the currently approved indications of renal cell carcinoma, metastatic melanoma and non-small cell lung cancer.
The modification of the “Dosage and Administration” section of the label replaces “the single dose regimen of nivolumab (3 mg/kg intravenously every two weeks) with the new recommended regimen of 240 mg IV every two weeks until disease progression or intolerable toxicity for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer.”
In addition, FDA said the nivolumab dosing regimen in combination with ipilimumab for melanoma will remain the same (nivolumab 1 mg/kg IV, followed by ipilimumab on the same day, every three weeks for four doses). However, after completion of ipilimumab, the recommended nivolumab dose will be 240 mg every two weeks until disease progression or intolerable toxicity, FDA added. The recommended dose for classical Hodgkin lymphoma remains 3 mg/kg IV, every 2 weeks until disease progression or intolerable toxicity, the agency said.
An FDA spokesman also told Focus: "One of the most compelling arguments to be made regarding flat dosing is the elimination of excess drug waste. Other considerations include convenience to health care providers and reduced concerns regarding accurate dosing in patients with weight fluctuations."
The agency based its approval on population pharmacokinetics analyses and dose/exposure-response analyses demonstrating the comparability of the pharmacokinetics exposure, safety and efficacy of the proposed new dosing regimen with the regimen that was previously approved.
“Based on simulations by the population pharmacokinetics model, FDA determined that the overall exposure at 240 mg every two weeks flat dose is similar (less than 6% difference) to 3 mg/kg every two weeks. These differences in exposure are not likely to have a clinically meaningful effect on safety and efficacy, since dose/exposure response relationships appear to be relatively flat in these three indications,” FDA added in a statement posted on Thursday.
Jaisy Wagner Styles, director of public affairs at Bristol-Myers Squibb, told Focus: "For the indications in non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) and unresectable or metastatic melanoma – this flat dose is intended to standardize dosing across all patients regardless of body weight and also to provide convenience to healthcare professionals in the preparation and administration of Opdivo (nivolumab).
"There is a broad range of patient weights across advanced RCC previously treated with anti-angiogenic therapy, previously treated metastatic NSCLC, and unresectable or metastatic melanoma as a single agent patients. Some patients will receive a slightly higher dose, some will receive a lower dose, and for others the dose will not change," she added.
Opdivo sales in 2015 totaled almost $1 billion worldwide.
Modification of the Dosage Regimen for Nivolumab
Tags: Opdivo, Bristol-Myers Squibb, Opdivo dosing
Regulatory Focus newsletters
All the biggest regulatory news and happenings.