LONDON - The U.S. Food and Drug Administration said on Friday it was unclear whether the benefits of GlaxoSmithKline’s experimental treatment for a common form of blood cancer outweigh the risks ahead of a review of a side-effect which affects the eyes.
Approval for belantamab mafodotin as a treatment for multiple myeloma, a rival to Johnson & Johnson and Genmab’s Darzalex treatment, is seen as important for GSK’s growing oncology portfolio. The FDA highlighted the frequency of the side effect, its severity, the lack of clear mitigation strategies and incomplete data on whether it is reversible.
“There is uncertainty whether the proposed dose modification strategy is sufficient to mitigate the risks,” a briefing document published on the FDA’s website said.Broker Jefferies said that while it was usual for the document to flag contentious issues, “our confidence is dented by FDA’s remarks”.
My mum died from MM, if this drug had been around I wouldn't have advised her to take it. With the treatment she had she lived a decent life, was happy and passed peacefully. Then again I'm lucky not to live in the US where it's all about the money 🤬🤬🤬
Hay there's a simple answer. My all-natural tonic stops COVID-19 and it's good for you. No side effects. It's doesn't test good but our ancestor used it thousands of years ago and they survived coronaviruses. Test it and see. It's free!
When has that recently stopped almost any pharma product from being released?
GSK.. all about themselves.. not people.
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