support@chatgptassignment.com

Please Read Below The Instructions

Pleaseread the following case study (and questions) carefully. Identify thekey words in the case study and perform a literature review using thesekey words. Provide a reference list with the references you identifiedfrom your literature search (please provide them in APA format).

Afteryou identify your reference list, use these references to answer thecase study question listed below. You will need to submit your responsesto 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 thetreatment of adult and pediatric patients (12 years and older andweighing at least 40 kg) with unresectable or metastatic melanoma. Thisreview was conducted under Project Orbis and used the Real-TimeOncology Review (RTOR) pilot program. This application was grantedpriority review, fast track designation, and orphan drug designation.

Please review the reference website provided below and answer the following questions:

  1. Whatis OPDUALAG treatment used for and how it is different from the otherestablished treatments options? You can discuss the importance of dual immunotherapy (OPDUALAG) over the nivolumab monotherapy.
  2. Whatare some regulatory considerations that BMS would have taken to gainapproval 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.
  3. Why would BMS receive priority review, fast track designation, and orphan drug designation from the FDA?
  4. 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.