Y-mAbs announces FDA approval of Danyelza for the treatment of Neuroblastoma
pharmafile | November 26, 2020 | News story | Business Services |
Y-mAbs Therapeutics has announced that the FDA has approved Danyelza in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment of relapsed or refractory high-risk neuroblastoma of the bone or bone marrow in patients at least one uear old.
This approval is an accelerated one due to an overall response rate and a duration of response. The FDA accepted the combination based on two clinical trials, which showed the drug was well tolerated with clinically manageable side effects. The approval relates specifically to patients who have demonstrated a partial response, minor response, or stable disease to prior therapy.
“We believe that Danyelza in combination with GM-CSF is a much-needed treatment for patients with relapsed/refractory high-risk neuroblastoma in the bone or bone marrow who have historically not had approved treatments available,” commented Claus Moller, Chief Executive Officer of Y-mAbs. “This approval of Y-mAbs’ first BLA represents a key step in working towards our mission of becoming a world leader in developing better and safer antibody-based oncology products addressing unmet pediatric and adult medical needs.”
Neuroblastoma is a solid tumor that emerges in the nervous system, outside of the brain. Some tumors are easily treatable, but the majority are very aggressive.
Thomas Gad, Founder, Chairman and President of Y-mAbs, added: “Today is an important day for children living with refractory/relapsed high-risk neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved.”
Conor Kavanagh
