The granting of conditional marketing authorization to Eli Lilly & Co.'s Lartruvo (olaratumab) by the EU Commission for the initial treatment of soft tissue sarcoma reflects the unmet need for the condition and growing flexibility shown by regulators to promising orphan drugs, forces that should combine into an acceptance of the drug by payers and regional health technology agencies in the region, analysts say.
Lartruvo's formal approval on Nov. 11 follows a recommendation for conditional marketing authorization from the European Medicines Agency in September as a new treatment for soft tissue sarcoma (STS). (Also see "Lilly’s Sarcoma Drug Lartruvo Latest To Test EU Conditional Approval System" - Pink Sheet, 26 September, 2016.) Having been designated as an orphan medicinal product by the EMA on Feb
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