• Regulatory NewsRegulatory News

    ICER on PD-1 Immunotherapies to Treat Lung Cancer: Lower the Prices

    In a new report on non-small cell lung cancer (NSCLC) treatments, the Institute for Clinical and Economic Review (ICER) found that for PD-1 immunotherapies, which are also often used to treat melanoma, the cost may be too high in terms of lengthening progression-free and overall survival. PD-1 immunotherapies target the checkpoint signaling pathway involving the programmed death 1 (PD-1) receptor, which can help protect tumor cells from being destroyed by the immune syst...
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    UK Patients With NSCLC to get Early Access to Tagrisso

    Patients in the UK with a specific form of non-small-cell lung cancer (NSCLC) will get early access to AstraZeneca's Tagrisso (osimertinib), following a positive opinion by the Medicines and Healthcare products Regulatory Agency (MHRA). Specifically, patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC will be able to access Tagrisso under the Early Access to Medicines Scheme (EAMS). EAMS was created to provi...
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    FDA Willing to Accept Different Endpoints When Assessing Lung Cancer Drugs

    Companies will be permitted to use several types of clinical trial endpoints to show the efficacy of drugs intended to treat non-small cell lung cancer (NSCLC), the US Food and Drug Administration (FDA) confirmed in a new guidance document released this week. The final guidance document, Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics , is intended to clarify the evidence FDA is willing to accept in the review of new NSCLC d...