ICYMI: Opdivo Now Approved for Patients Aged 12+ with Surgically Resected Stage 2B-C Melanoma


In the past, the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) for different forms of cancer, such as non-small cell lung cancer (NSCLC) and melanoma. More recently, in October 2023, the FDA expanded its approval of the drug. Cure Today reports that the expanded approval means that Opdivo is now approved for those ages 12+ with stage 2B or 2C melanoma that has been surgically resected. Many people falsely believe that surgical resection means that their cancer is gone in totality. However, an estimated 33% of people with stage 2B melanoma, and 50% of those with stage 2C melanoma, experience relapse within five years of the original surgery.

Because of this high rate of recurrence, it’s necessary to identify treatments that can reduce the risk and improve survival. Opdivo was shown to do just that in the Phase 3 CheckMate-76K study. During the study, researchers compared outcomes from Opdivo versus a placebo. They found that:

  • Opdivo treatment reduced the risks of death, melanoma recurrence, or new-onset melanoma by 58% in this particular patient population.
  • 93% of people with surgically-resected stage 2B melanoma, and 84% of those with surgically-resected stage 2C melanoma, had no signs of recurrence within one year following treatment. Alternately, on the placebo, the percentage was 84% and 72% respectively.
  • Opdivo is relatively well-tolerated and safe to use. Some people may experience side effects, however, that include fatigueloose bowel movementsitchiness or rashes, and musculoskeletal pain.

About Melanoma

Melanoma is a serious form of skin cancer that forms in melanocytes, or melanin-producing cells. While it may not be as common as other skin cancers, melanoma does carry a high risk of spreading: sometimes to areas like the eyes or internal organs. This cancer often manifests on areas of the body with high sun exposure, such as the shoulders, trunk, hips, head, or neck in males, or arms and legs in females. Having a fair complexion also increases the risk of melanoma. People with darker skin often develop melanoma in more “hidden” spots such as the genitals, urinary or digestive tract, mouth, or under nails.

Doctors have noted that, in recent years, the rate and risk of melanoma has been rising over the years. Signs of this cancer may include a new mole growing near an existing mole, skin color changes, or spots on the skin that are changing in shape, size, and color. One way that you can identify if a mole is abnormal is by using the ABCDE method.

For example, abnormal moles may have an Asymmetrical shape, an irregular Border (that is ragged or notched), Changing Colors, a Diameter of 1/4 inch or larger, and Evolution over time: becoming larger, itchier, or different colors. Abnormal moles may also crust and bleed.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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