USFDA rejects Y-mAbs Therapeutics pediatric cancer drug Omburtamab

Omburtamab was being developed to treat cancer in the cerebrospinal fluid that provides nutrients and chemicals to the brain and spinal cord.

Published On 2022-12-03 08:00 GMT   |   Update On 2022-12-03 08:00 GMT
Advertisement

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.
Advertisement
"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.
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

Tags:    
Article Source : Reuters

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News