IQWiG, the German health technology assessment institute, says that there is no proof of additional benefit for Roche’s orphan drug Polivy (polatuzumab vedotin) for first line diffuse large B-cell lymphoma (DLBCL) compared with alternatives.
German HTA Queries Polivy Benefits Amid Lack Of Evidence
Roche’s lymphoma drug Polivy could face pricing challenges in Germany as it undergoes a full benefit assessment.

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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.