FDA approves Bristol-Myers Squibb’s skin cancer drug
pharmafile | October 29, 2015 | News story | Sales and Marketing | BMS, Bristol-Myers Squibb, Yervoy, ipilumumab, melanoma
The FDA has recommended Bristol-Myers Squibb’s cancer drug Yervoy (ipilimumab) for the adjuvant treatment of patients with melanoma.
The drug, in a 10 mg/kg dose, will also be given to patients with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection including total lymphadenectomy.
Resectable stage III melanoma represents 5%, or approximately 3,100 cases, of all new melanoma cases diagnosed annually. This stage of melanoma can be aggressive, with a 60% risk of recurrence after surgery. Yervoy is approved by the FDA but has a boxed warning as it can result in severe to fatal adverse reactions to the immune system and organs.
Michael Giordano, senior vice president, head of development, oncology at Bristol-Myers Squibb says: “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.” He went on to says: “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 tumour types and at many stages of disease.”
The approval is based on clinical data from a Phase III trial which demonstrated Yervoy 10 mg/kg, used as an adjuvant, significantly improved recurrence-free survival compared to placebo, with a 25% reduction in the risk of recurrence or death.
Despite the risk of disease recurrence among Stage III melanoma in patients following resection, there are limited treatment options available to help reduce the risk of recurrence after surgery.
To help ensure patient access to Yervoy, Bristol-Myers Squibb is offering a new patient assistance program – the Adjuvant Patient Program for Melanoma. Through this program, eligible patients who have been prescribed Yervoy 10 mg/kg for the adjuvant treatment may receive Yervoy 10 mg/kg free of charge.
Yasmita Kumar
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