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  • USFDA rejects Y-mAbs...

USFDA rejects Y-mAbs Therapeutics pediatric cancer drug Omburtamab

Ruchika SharmaWritten by Ruchika Sharma Published On 2022-12-03T13:30:38+05:30  |  Updated On 3 Dec 2022 1:30 PM IST
USFDA rejects Y-mAbs Therapeutics pediatric cancer drug Omburtamab
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Omburtamab was being developed to treat cancer in the cerebrospinal fluid that provides nutrients and chemicals to the brain and spinal cord.

New Delhi: The U.S. health regulator on Thursday declined to approve a treatment from Y-mAbs Therapeutics for a rare form of nerve cancer in pediatric patients, dragging the company's shares down 16 percent in extended trading.

Y-mAbs said it is assessing the implications of the Food and Drug Administration's complete response letter (CRL) and the company's plans for the drug's development program.
The FDA's decision follows a unanimous vote by its advisers in October against the drug, omburtamab, to treat neuroblastoma due to insufficient evidence that it improves overall survival.
"We are disappointed but not surprised based on the outcome of the (FDA advisory panel) meeting," interim Chief Executive Officer Thomas Gad said in a statement.
The FDA and its advisers had raised issues over the strength of the data and uncertainty over trial results.
Read also: COVID-19 Treatment : Eli Lilly's Bebtelovimab no longer authorized by USFDA
The company already has a neuroblastoma drug Danyelza, approved in 2020, which generated $32.8 million in revenue in the first nine months of 2022.
Omburtamab was being developed to treat cancer in the cerebrospinal fluid that provides nutrients and chemicals to the brain and spinal cord.
Danyelza, on the other hand, is approved for the treatment of relapsed or refractory neuroblastoma in the bone or bone marrow.

Read also: Zydus Lifesciences secures USFDA approval for Estradiol Transdermal System to treat menopause symptoms

USFDAY-mAbs Therapeuticsnerve canceromburtamabneuroblastoma
Source : Reuters
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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