Roche Beats Rivals To Japan Tumor-Agnostic Market With World-First Rozlytrek Nod
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.
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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.
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of 25 June to 1 July was another slow one for approvals, with no new PMAs, panel-track PMA supplements, or de novos. Japan’s MHLW approved Foundation Medicine’s companion diagnostic for Roche’s cancer drug Rozlytrek.
Japan grants first approval worldwide for Daiichi Sankyo's oral FLT3 inhibitor, marking progress for Japanese firm's global oncology ambitions.