Roche’s EU Accelerated Assessment Bid For Tumor Agnostic Entrectinib Backfires
A decision to yoke together two indications in one EU accelerated assessment filing for the anticancer has backfired on Roche and left the product at even more of a disadvantage compared with Bayer’s Vitrakvi in the tumor-agnostic setting.
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The German group's cancer drug is the first to be approved for use in Europe for a wide range of tumors. The principal challenge now is to find eligible patients.
Companies pleased at gaining an EU accelerated assessment for a product should be aware that the agency offers no guarantee that they will get to keep it. Novartis’s Zolgensma is one of seven drugs whose review the EMA has taken off the fast track.
Roche’s tumor-agnostic drug receives first approval globally in Japan following an expedited review, giving the Swiss group a lead over its rival in this market. But sales may be limited.