New approved treatment for melanoma

30 Jan 2015

The US Food and Drug Administration has granted accelerated approval to nivolumab (trade name: Opdivo). The approval is for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab (and, if BRAF V600 mutation positive, a BRAF inhibitor).

Promising clinical results in the first 120 patients

Approval was based on objective response rate and durability of response in the first 120 patients who were treated with nivolumab. They had a minimum 6 months follow-up from an on-going, randomized, open-label trial of 370 patients with unresectable or metastatic melanoma.

In order to participate on the trial, patients were required to have

  • disease progression following ipilimumab
  • a BRAF inhibitor if BRAF V600 mutation positive
  • no autoimmune disease or a history of severe ipilimumab-related adverse reactions.


The clinical benefit still to be demonstrated

The adverse reactions among the 268 patients receiving nivolumab were:

  • rash (greater than or equal to 20%) and
  • abdominal pain
  • hyponatremia
  • increased aspartate aminotransferase and
  • increased lipase.

Clinically significant immune-mediated adverse reactions included:

  • pneumonitis
  • colitis
  • hepatitis, nephritis/renal dysfunction
  • hypothyroidism and
  • hyperthyroidism.

As a condition of this accelerated approval, Bristol-Myers Squibb (the drug's manufacturer) is required to conduct one or more multicenter, randomized trial(s) establishing the superiority of nivolumab over standard therapy in adult patients with unresectable or metastatic melanoma to verify and describe the clinical benefit of nivolumab. 

Details on Nivolumab's medical function

Nivolumab, a therapy given "breakthrough" status, is a monoclonal antibody that binds to the receptor known as PD-1 ("Programmed cell Death 1" protein) and blocks its interaction with PD-L1 and PD-L2 ("Programmed Death Ligand" 1 & 2, respectively). This way it releases PD-1 pathway-mediated inhibition of the immune response, including anti-tumor immune response.


Source: eCancer News
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