BMS has chalked up a strong win this week, with its immuno-oncology treatment Yervoy (ipilimumab) becoming the first and only agent to receive EU approval to treat paediatric patients with skin cancer.
More specifically, Yervoy is now approved to treat patients 12 years and older for metastatic or unresectable melanoma, expanding its indications following an initial approval as an adjuvant treatment for patients with cutaneous melanoma.
The EU green light will be welcomed news after BMS saw the big-selling melanoma drug flop in a head-to-head trial with Merck & Co’s Keytruda (pembrolizumab), which was found to be more effective than Yervoy with patients reporting a better PFS with fewer side effects.
Commenting on the drug’s new indication Fouad Namouni, head of development, oncology at Bristol Myers Squibb, said: “The expanded EU indication of Yervoy for paediatric patients with unresectable or metastatic melanoma is an outcome of BMS’s unyielding commitment to advancing treatments for patients with unmet clinical needs.
“With this approval, we’re able to provide an alternative to young patients whose treatment options have traditionally been limited.”
Yervoy gained its approval on the back of two clinical trials, with data showing the overall safety profile for children and adolescents of Yervoy was consistent with that for adults.
The European approval follows a decision by the US Food and Drug Administration’s (FDA) to approve the drug for the same indication back in July last year.
However, Merck & Co’s leading position in the cancer immunotherapies market is so far unmatched, with Keytruda picking up more indications, most recently in lung cancer. Analysts have suggested that Keytruda’s recent data in that indication will ‘solidify’ Merck’s lead in first-line NSCLC.