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                Resources for Information | Approved Drugs

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                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
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          FDA D.I.S.C.O.: Nivolumab for adjuvant treatment of patients with melanomaResources for Information | Approved Drugs FDA D.I.S.C.O.: Nivolumab for adjuvant treatment of patients with melanoma
  
  	
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FDA medical oncologists discuss the December 20, 2017, approval of nivolumab for the adjuvant treatment of patients with melanoma.

Sanjeeve Bala: Welcome back to the DISCO. Today’s Drug Information Soundcast in Clinical Oncology from FDA’s Oncology Center of Excellence discusses the recent approval of nivolumab, marketed as Opdivo, for a new indication, for the adjuvant treatment of patients with melanoma at high risk for relapse.

Abhilasha Nair: Hi, I’m Abhi Nair, a medical oncologist at the Oncology Center of Excellence here at the FDA. Nivolumab has been approved for patients with metastatic melanoma since 2014, both as a single agent and in combination with ipilimumab. Complete surgical resection of stage III and IV melanoma may lead to a cure in some cases, but relapse is common, with an estimated 5-year overall survival of 11 to 20 percent. Patients with stage IV melanoma who relapse after surgical resection do even worse, with a median overall survival of 21 months.

SB: I’m Sanjeeve Bala, a medical oncologist and acting clinical team leader at FDA. The current approval expands the use of nivolumab to the adjuvant setting in some patients with melanoma. Specifically, nivolumab is approved for the adjuvant treatment of patients with melanoma with involvement of lymph nodes, and also for patients with metastatic disease who have undergone complete resection.

AN: Sanjeeve, what are some of the adjuvant treatments previously approved by FDA to prevent relapse in patients who are at high risk for recurrence?

SB: Abhi, there were three FDA-approved adjuvant treatments for melanoma: interferon alpha, peginterferon alpha, and most recently, ipilimumab, which was approved in 2015. This latter approval marked the beginning of the new immunotherapy era in medical oncology. In the pivotal trial that led to the ipilimumab approval, patients treated with ipilimumab had improved relapse-free survival of 26 months vs. 17 months for patients given placebo.

AN: Sanjeeve, what clinical data supported this new approval of nivolumab for the adjuvant treatment of melanoma?

SB: Abhi, the approval was based on improvement in recurrence-free survival in a large, randomized, double-blind trial, CHECKMATE-238. In this trial, 906 patients who had completely resected stage IIIB or C or stage IV melanoma with negative margins, were randomly allocated to receive either nivolumab or ipilimumab. Patients on both trial arms also received matching placebos of the other drug.

AN: Let’s talk about endpoints. How was recurrence-free survival defined?

SB: Abhi, it was a pretty standard definition: the time between the randomization date and the date of first local or regional recurrence, or distant metastasis; new primary melanoma; or death from any cause, whichever occurred first.

AN: Now let’s hear the efficacy results.

SB: Patients in the nivolumab arm experienced fewer recurrences or deaths: 34 percent, compared with 45.5 percent in the ipilimumab arm. The hazard ratio for recurrence or death on the study was a statistically significant 0.65 in favor of the nivolumab arm. Median recurrence-free survival was not reached on either arm.

AN: That’s impressive. Was nivolumab granted breakthrough designation for this indication?

SB: Yes, Abhi, it was. And the application was granted priority review and approved two months ahead of the goal date.

AN: Sanjeeve, what is the recommended dose and schedule for this indication?

SB: The recommended dose of nivolumab for the adjuvant treatment of melanoma is 240 mg administered as an IV infusion over 60 minutes every two weeks until disease recurrence or unacceptable toxicity, for a maximum of one year. In the trial, the median duration of nivolumab exposure was 11.5 months, and 74 percent of patients received nivolumab for greater than 6 months.

AN: Sanjeeve, since nivolumab has been approved for a few years now and is being used in the community for later-stage disease, it already has a robust safety database and a well-known safety profile. Were there any new safety findings?

SB: Abhi, in general, nivolumab appeared to be better tolerated than ipilimumab in this trial. No new safety signals were identified for nivolumab. Detailed safety information is available in the prescribing information, which may be found on the FDA website.

AN: Sanjeeve, give us the three take-home points from this DISCO.

SB: Sure, Abhi. The three main take-away points are: 1) With this approval, nivolumab is indicated for the adjuvant treatment of patients with melanoma who have undergone complete resection but are at high risk of recurrence based on involvement of regional lymph nodes or metastatic disease. 2) The recommended dosing for this indication is 240 mg IV every 2 weeks until disease recurrence or unacceptable toxicity for up to one year, and 3) The safety profile of nivolumab was consistent with the known safety profile of nivolumab for other approved indications.

SB: For a transcript of this Soundcast with a link to the prescribing information, visit the FDA Oncology Center of Excellence DISCO website at www.fda.gov/DISCO.

AN: Thank you, Sanjeeve. Are there other FDA oncology drug approvals that you would like to hear about? Leave us your questions and comments on Twitter @FDAOncology or email us FDAoncology@fda.hhs.gov. And as always, we welcome your feedback. I’m Abhi Nair, thank you so much for tuning in to DISCO today.

SB: And until next time at the DISCO, I’m Sanjeeve Bala.

Acknowledgements:

This Drug Information Soundcast in Clinical Oncology was developed by Abhilasha Nair, Sanjeeve Bala, Ashley Ward, Maitreyee Hazarika, Kirsten B. Goldberg, and Richard Pazdur, of the Oncology Center of Excellence and the Office of Hematology and Oncology Products. Steven Jackson of the Division of Drug Information was the sound producer.

                                                                                  Content current as of:
      05/03/2018
              
              
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						  OncologyResources for Information | Approved Drugs

          
                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
          Verified Clinical Benefit | Cancer Accelerated Approvals
          Withdrawn | Cancer Accelerated Approvals
          Other | Cancer Accelerated Approvals


                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description
 
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