Ono Pharma Korea and Bristol-Myers Squibb Korea said Monday their anti PD-1 treatment Opdivo (ingredient: nivolumab) gained another indication for BRAF V600 mutation-positive unresectable or metastatic melanoma.
“We are pleased to relay the hopeful news to medical professionals and patients of the expanded indication for melanoma, following the expanded indications for five other carcinomas and insurance coverage of non-small cell lung cancer,” BMS Korea한국BMS제약 CEO Park Hye-seon박헤선 said. “We will do our best to improve patients' access to treatment so Opdvio can become a representative immunotherapy drug.”
The Ministry of Food and Drug Safety’s approval given Friday lets Opdivo be used as a first-line monotherapy for metastatic or unresectable melanoma, regardless of BRAF mutational status. The ministry's go-ahead also allows the drug to treat the cancer types in combination with Yervoy, the companies said.
The anti PD-1 immunotherapy now tallies a total of seven indications in Korea.
Melanoma is the most dangerous form of skin cancer that develops when unrepaired DNA damage to skin cells triggers mutations. There are an estimated 3,200 Korean patients, the companies said.
“We find the added indication significant in expanding the scope of treatment for melanoma patients,” Ono Pharma Korea한국오노약품공업 CEO Kunihiko Ito said.
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