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In combination with Pd or Kd, isatuximab (10 mg/kg) is administered by IV infusion on days 1, 8, 15, and 22 (weekly, QW) in cycle 1 and on days 1 and 15 (every 2 weeks, Q2W) from cycle 2

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Are there any local standards or additional testing requirements beyond international standards for medical devices in Australia per TGA regulations