Withdrawal of the EU Marketing Authorisation Applications for Cavoley and Efgratin
Both contain the active substance pegfilgrastim and were developed as a biosimilar medicine
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Both contain the active substance pegfilgrastim and were developed as a biosimilar medicine
Approval is based on results from the HERCULES trial
Recommendations follow EMA’s review of substances classified as probable human carcinogens
It is indicated in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of metastatic squamous NSCLC
It is indicated in combination with bevacizumab, paclitaxel and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC
It is indicated as monotherapy in the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR activating mutations
Genomic, epigenomic, and transcriptomic changes described in pre-invasive lesions
More evidence on axicabtagene ciloleucel is being collected
Discovery of therapeutically targetable chordoma oncogenic dependencies
It is estimated that around 1,000 patients are currently treated in the EU
More evidence on nivolumab is being collected
Approval is based on results from two open-label, randomised, active-controlled, non-inferiority phase III studies
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