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BMS’ Yervoy receives additional FDA approval

Gives the nod for Yervoy as adjuvant treatment option for melanoma

The FDA has approved Bristol Myers Squibb's Yervoy for the adjuvant treatment of patients with resectable stage III melanoma.

The approval comes on the back of data of a phase III trial which showed that Yervoy (ipilimumab) at 10mg/kg, used as an adjuvant, significantly improved recurrence-free survival compared to placebo. Additionally there was a 25% reduction in risk of death or reoccurrence.

Michael Giordano, senior VP and head of development of Oncology at Bristol-Myers Squibb, said: “The science of immuno-oncology is rapidly advancing, and we are proud to be the first to demonstrate the potential of an immune checkpoint inhibitor in the adjuvant setting, an earlier stage of the disease, where patients urgently need new medicines.

“The approval of Yervoy for the treatment of adjuvant melanoma underscores our scientific leadership in immuno-oncology, with a commitment to further developing our I-O agents - Yervoy and Opdivo - across multiple tumor types and at many stages of disease.”

Resectable stage III melanoma represents approximately 3,100 of all new melanoma cases diagnosed annually and there is a 60% risk of recurrence after surgery.

Yervoy currently has a boxed warning stating that the drug can result in severe to fatal immune-mediated adverse reactions.

To ensure patients have access to Yervoy at the adjuvant setting of 10mg/kg dose, BMS is offering a new patient assistance program – the Adjuvant Patient Program for Melanoma. 

Although Yervoy achieved sales of $1.3bn in 2014, earlier this year Merck & Co's PD-1 inhibitor Keytruda (pembrolizumab) significantly outperformed the drug in patients with unresectable stage III or IV advance melanoma and it is likely to face stiff competition over the next few years.

Article by
Nikhil Patel

30th October 2015

From: Regulatory



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