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Ipsen: fast track for Onivyde, targets sales growth

(CercleFinance.com) - Ipsen has announced that it has received "Fast Track" designation from the US FDA for liposomal irinotecan injection (Onivyde) as a monotherapy in the second-line treatment of small cell lung cancer (SCLC).


It is currently approved in the US and Europe, in combination with fluorouracil and leucovorin, for patients with metastatic adenocarcinoma of the pancreas, whose disease has progressed after treatment with gemcitabine.

A Phase III randomised study is underway to assess the efficacy and safety of its experimental use as a monotherapy in patients with SCLC who have progressed during or after a first-line platinum-based treatment.

Separately, at its virtual CMD, Ipsen announced that it is targeting average annual sales growth of +2%-+5% over 2020-24, including the potential approval of additional indications.

It plans to cut SG&A expenses as a percentage of net sales, enabling it to increase R&D efforts as a percentage of sales to reinforce its external innovation strategy.


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