Seattle Genetics Win Early US FDA Approval For Tukysa, Plans Rapid Launch
Tucatinib, approved for advanced unresectable or metastatic HER2-positive breast cancer, has a list price of $18,500 per month or $111,000 for a full course. Doctors can order the drug immediately.
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Chief medical officer Roger Dansey has stepped in as interim CEO until a new one is appointed.
The US FDA-led initiative for collaborative submission and review of new cancer drugs has produced a number of benefits since it was introduced in 2019, including more “robust” regulatory decisions and earlier market access, the DIA Europe 2022 conference heard.