New drug for neuroblastoma! The new GD2 target antibody Danyelza was given priority by the FDA, and the total mitigation rate of the joint GM-CSF was as high as 78%!

June 04, 2020 /
PRNewswire
bioON/--Y-mAbs is a late-stage, clinical biopharmaceutical company dedicated to the development and commercialization of new, antibody-based cancer treatment productsThe company has a broad and advanced product line, including two key phase candidates, Danyelza (naxitamab) and omburtamab, which targettumorthat express GD2 and B7-H3, respectivelyrecently, the company announced that the U.SFood and Drug Administration (
The FDA) has accepted Danyelza's biological product licensing application (BLA) for the treatment of recurrent/incurable high-risk neuroblastoma and granted priority review, with a target action date of November 30, 2020The agency also indicated in the BLA acceptance letter that it did not intend to convene an advisory committee to discuss the application at this timeneuroblastoma is a highly invasive tumor, one of the most commontumorin infants and young children, and although enhanced multi-mode therapy has improved survival rates in recent years, survivors have a high risk of recurrencenaxitamab is a humanoid monoclonal antibody that targets GD2 antigens, which are expressed on tumor surfaces produced in the neuroblastoma layer, including neuroblastoma,melanomaand osteosarcomaBy binding to GD2 antigens on the tumor surface, naxitamab can trigger antibody-mediated cytotoxic reactions and activate the tonic system in the immune system, thus killingtumor
currently, naxitamab is being clinically developed to treat recurrent/incurable high-risk neuroblastoma, osteosarcoma, and other GD2-positivetumorIn the United States, the FDA has granted naxitamab an orphan drug (ODD) for the treatment of neuroblastoma and osteosarcoma, and in August 2018, theFDAgranted naxitamab breakthrough drug eligibility (BTD) to treat high-risk neuroblastoma in a joint GM-CSFThomas Gad, founder, chairman, president and head of business development and strategy atY-mAbs, who is a long-term father of high-risk neuroblastoma survivors, said, "we believe thatFDAto take our BLA as a priority, which is a major achievement for Y-mAbs and a key step forward." If approved, Danyelza will be able to address the large unmet medical needs present in the group of children with recurrent/incurable high-risk neuroblastomaWe look forward to working with the agency to bring Danyelza to eligible patientsIf approved, we plan to seamlessly launch Danyelza commercially "
naxitamab mechanism (Photo: Y-mAbs website) naxitamab BLA based on security and validity data for two key Phase II studies (201 and 12-230) In October last year, Y-mAbs presented data on the naxitamab joint GM-CSF treatment relapse/incurable high-risk neuroblastoma study (NCT01757626) at the International Society for Oncology (SIOP) in Lyon, France a subgroup of the study included 28 patients with primary refractory high-risk neuroblastoma who were ineffective with intensive induction therapy and more than half of patients were also incurable with second-line chemotherapy In the study, the patients received a combination of naxitamab and GM-CSF The results showed that the objective remission rate (ORR) was 78% and 50% of patients had no progressive survival (PFS) for 24 months another subgroup of the study included 35 children with recurrent neuroblastoma that was resistant to salvage therapy, 30 of which were able to assess efficacy One-third of patients had the disease relapsed two or more times before the study, and 89 percent had been treated with anti-GD2 medication In this group of patients, the total remission rate (ORR) of the combination of naxitamab and GM-CSF was 37%, indicating that the treatment programme had significant clinical benefits in such refractory patients researchers at the memorial Sloan Kettering Cancer Center (MSK) developed naxitamab, a drug exclusively licensed by MSK to Y-mAbs As a result of this license agreement, MSK has institutional financial interest stake in the product and Y-mAbs (biovalleybioon.com) original source: Y-m Abs Announces U.S.
FDA Acceptance of Biologics License app the lication for Danyelza ™ (naxitamab) for the Treatment of Neuroblastoma for Priority Review