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F.Y.-V. Pham on Muck Rack

F.Y.-V. Pham

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Added therapeutic benefit regarding ESMO-MCBS and French health technology assessment of drugs granted early access program

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By E. Jacquet, F.Y.-V. Pham, A. Monard, L. Brunel
| annalsofoncology.org
In recent decades, novel anticancer drugs have improved survival outcomes, but with rising costs. Prolonged negotiations between manufacturers and national authorities can postpone market access and raise ethics issues. To overcome this delay, France has created a temporary authorization for use (ATU) program allowing access to drugs before Marketing Authorization (MA). ATUs are granted to drugs with positive benefit/risk balance to treat patients with unmet medical needs, based on available data.
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