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FDA has approved Opdivo as adjuvant therapy in patients with completely resected melanoma with lymph node involvement or metastatic disease


The U.S. Food and Drug Administration ( FDA ) has approved Opdivo ( Nivolumab ) injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
The purpose of adjuvant therapy is to reduce the risk of recurrence following surgical removal of the tumor and lymph nodes that contain cancer.

In the phase 3 CheckMate -238 trial, Nivolumab significantly improved recurrence-free survival ( RFS ) versus an active comparator, Ipilimumab ( Yervoy ), in patients with stage IIIB/C or stage IV melanoma after surgery.
This benefit was observed across important subgroups, including in both BRAF mutant and BRAF wild-type patients.

In the CheckMate -238 clinical trial, Nivolumab has demonstrated an 18-month RFS rate of 66.4% [ 95% confidence interval ( CI ): 61.8 to 70.6 ] compared with 52.7% for Ipilimumab ( 95% CI: 47.8 to 57.4 ), with the median RFS not yet reached in either group.
Nivolumab has reduced the risk of disease recurrence by 35% versus Ipilimuamb [ hazard ratio ( HR ): 0.65; 95% CI: 0.53 to 0.80; p less than 0.0001 ].

Opdivo is associated with the following Warnings and Precautions: immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions; infusion reactions; and embryo-fetal toxicity.
Yervoy has a Boxed Warning regarding immune-mediated adverse reactions.

Opdivo received Breakthrough Therapy Designation from the FDA for the adjuvant treatment of patients with high-risk, fully resected melanoma in September 2017.
Approximately three in every 10 patients with stage III melanoma currently receive adjuvant therapy after surgery.
Even with available treatment options, the majority of stage IIIB and IIIC melanoma patients ( 71% and 85%, respectively ) experience disease recurrence within five years.

Opdivo is the first programmed death-1 ( PD-1 ) immune checkpoint inhibitor to demonstrate superiority, including better tolerability, versus Yervoy, a standard of care in this patient population.
Based on data from the CheckMate -238 trial, the National Comprehensive Cancer Network ( NCCN ) recently added Nivolumab to its treatment guidelines for completely resected stage IIIB/C melanoma and completely resected stage III melanoma with clinical satellite or in-transit metastases.

In CheckMate -238, adverse events leading to discontinuation were reported in 9% of Nivolumab-treated patients ( n=44/452 ) and in 42% of Ipilimumab-treated patients ( n=193/453 ).
Adverse reactions leading to one or more omitted doses occurred in 28% of patients who received Nivolumab.
Grade 3 or 4 adverse events were experienced by 25% of patients ( n=115/452 ) in the Nivolumab group and 55% of patients ( n=250/453 ) in the Ipilimumab group.
Serious adverse reactions occurred in 18% of patients treated with Nivolumab. ( Xagena )

Source: BMS, 2017

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