Drug Combo Wins OK as First Line in Kidney Cancer | IUK Med Online
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Drug Combo Wins OK as First Line in Kidney Cancer

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Medpage Today

Drug Combo Wins OK as First Line in Kidney Cancer

As shown in Checkmate 214 study, ipilimumab + nivolumab improve survival

MedpageToday

  • by Managing Editor, MedPage Today

WASHINGTON — The combination of ipilimumab (Yervoy) and nivolumab (Opdivo) can be used to treat intermediate- to poor-risk patients with previously untreated renal cell carcinoma, the FDA said Monday.

Approval was based on the Checkmate 214 trial, which found an 18-month overall survival rate of 75% with the combination, compared with 60% among patients treated with sunitinib (Sutent).

The trial was stopped early, in September 2017, when interim analysis identified a clear survival benefit with the combination.

“The recommended schedule and dose for this combination,” the FDA said in announcing the approval, “is nivolumab, 3 mg/kg, followed by ipilimumab, 1 mg/kg, on the same day every 3 weeks for four doses, then nivolumab, 240 mg, every 2 weeks or 480 mg every 4 weeks.”

Adverse effects include fatigue, rash, diarrhea, myalgia, arthralgia, pruritus, nausea, cough, pyrexia, and decreased appetite.

Both drugs are sold by Bristol-Myers Squibb. The combination had been designated as “breakthrough therapy” and underwent priority review.

2018-04-16T14:45:00-0400
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Medpage Today

Drug Combo Wins OK as First Line in Kidney Cancer

As shown in Checkmate 214 study, ipilimumab + nivolumab improve survival

MedpageToday

  • by Managing Editor, MedPage Today

WASHINGTON -- The combination of ipilimumab (Yervoy) and nivolumab (Opdivo) can be used to treat intermediate- to poor-risk patients with previously untreated renal cell carcinoma, the FDA said Monday.

Approval was based on the Checkmate 214 trial, which found an 18-month overall survival rate of 75% with the combination, compared with 60% among patients treated with sunitinib (Sutent).

The trial was stopped early, in September 2017, when interim analysis identified a clear survival benefit with the combination.

"The recommended schedule and dose for this combination," the FDA said in announcing the approval, "is nivolumab, 3 mg/kg, followed by ipilimumab, 1 mg/kg, on the same day every 3 weeks for four doses, then nivolumab, 240 mg, every 2 weeks or 480 mg every 4 weeks."

Adverse effects include fatigue, rash, diarrhea, myalgia, arthralgia, pruritus, nausea, cough, pyrexia, and decreased appetite.

Both drugs are sold by Bristol-Myers Squibb. The combination had been designated as "breakthrough therapy" and underwent priority review.

2018-04-16T14:45:00-0400
Comments

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.



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