AstraZeneca’s call to speed approval of cancer drug rejected by US panel

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Pharmaceutical_LargeSource: The Guardian – Julia Kowelle.

AstraZeneca has suffered a setback after a panel of US health experts rejected its request for accelerated approval of a new ovarian cancer drug.

The surprise decision by the US FDA’s Oncologic Drugs Advisory Committee comes at a delicate time, with Britain’s second-largest drugsmaker working hard to deliver on its drug pipeline after fighting off a £69bn takeover approach from bigger US rival Pfizer last month. Any setbacks on new medicines could stir discontent among AstraZeneca shareholders, some of whom wanted the board to engage further withPfizer.

The FDA panel asked the AstraZeneca to submit further clinical data on olaparib, a maintenance therapy for relapsed ovarian cancer which is in mid-stage clinical trials.

The data is due at the end of 2015, but AstraZeneca had hoped to get the green light for the treatment from the FDA in October. Chief medical officer Briggs Morrison said the company was disappointed by the decision.

While the setback should have little impact on AstraZeneca’s future revenues and profits, investors and analysts are watching closely for any slip-up in its R&D efforts.

New medicines are key to its ambitious forecast of a 75% jump in revenues from $26bn to over $45bn by 2023, a key plank of the defence strategy outlined by chief executive Pascal Soriot. At the heart of it are new cancer immunotherapy treatments…read more.


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