Description
Please read the following case study (and questions) carefully. Identify the key words in the case study and perform a literature review using these key words. Provide a reference list with the references you identified from your literature search (please provide them in APA format).
After you identify your reference list, use these references to answer the case study question listed below. You will need to submit your responses to this case study along with your reference sheet for grading. The case study should answer all questions and should be around 750-1000 words (excluding references).
Case Study:
Bristol Myers Squibb (BMS) received approval for OPDUALAG from FDA on 18 March 2022, for the treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma. This review was conducted under Project Orbis and used the Real-Time Oncology Review (RTOR) pilot program. This application was granted priority review, fast track designation, and orphan drug designation.
Please review the reference website provided below and answer the following questions:
What is OPDUALAG treatment used for and how it is different from the other established treatments options? You can discuss the importance of dual immunotherapy (OPDUALAG) over the nivolumab monotherapy.
What are some regulatory considerations that BMS would have taken to gain approval for OPDUALAG? You can discuss the set-up of the RELATIVITY-047 trial here. Explain how progression-free survival (PFS) was used as a major efficacy outcome measure.
Why would BMS receive priority review, fast track designation, and orphan drug designation from the FDA?
Briefly explain the Project Orbis and Real-Time Oncology Review (RTOR) pilot program initiatives by the FDA.
Reference:
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-opdualag-unresectable-or-metastatic-melanoma#:~:text=FDA%20approves%20Opdualag%20for%20unresectable%20or%20metastatic%20melanoma,-Share&text=On%20March%2018%2C%202022%2C%20the,with%20unresectable%20or%20metastatic%20melanoma.
