PD-L1 status on immune cells or tumor cells was considered to be one of the first potential predictive biomarkers for response to ICI treatment (6). Three of these approved ICIs targeting the PD-1/PD-L1 pathway (Keytruda (pembrolizumab), Opdivo (nivolumab), and Tecentriq (atezolizumab)) ...
3、18Predictability:Meeting PDUFA Goals.19Access:First Cycle Approvals and First in U.S.Approvals.20New Uses of Approved Drugs.23Approved Drugs Expanded for New Pediatric Populations.25Biosimilar and Interchangeable Biosimilar Approvals.28Other Non-Novel Approvals.30Conclusion.33Appendix A:CDERs Novel...
3、Therapy 11Priority Review11Accelerated Approval12Overall Use of Expedited Development and Review Methods 12Predictability:Meeting PDUFA Goals 13Access:First Cycle Approvals and First in US Approvals 14New Uses of Approved Drugs 16Approved Drugs Expanded for New Pediatric Populations 18Biosimilar App ...
Merck & Co has voluntarily withdrawn its Keytruda immunotherapy from a lung cancer niche in the US, amid a crackdown by the FDA on drugs approved without the required post-marketing data. Keytruda had been granted accelerated approval in metastatic small
The ODAC discussed this question through data supporting the current approvals of nivolumab (Opdivo) and pembrolizumab (Keytruda) plus chemotherapy, as well as the application of tislelizumab-jsgr (Tevimbra) plus chemotherapy, for this indicatio...
the clearances were not specific to any analyte or clinical application. A device such as the widely-used Vacutainer would be cleared for use with blood, without trying to limit the diagnostic uses of the blood. However, in recent years, particularly for blood collection devices, FDA has requir...
Alpine said it has voluntarily terminated enrollment in two clinical trials of the drug following the death. While the first trial was evaluating Davoceticept as a monotherapy, the second was evaluating the drug in combination with Keytruda.
Each year the U.S. approves dozens of new uses for cancer drugs based on early signs that they can shrink or slow the spread of tumors.
The test, TriNetra, uses proprietary technology to detect Circulating Tumor Cells (CTCs) specific to breast cancer. In previous studies, the device detected Stage 0 and Stage 1 cancers with high accuracy. Specifically, TriNetra is approved for asymptomatic women over the age of 40...
In an earlier phase 2 study, margetuximab in combination with pembrolizumab (Keytruda), a PD-1 inhibitor, demonstrated promising survival findings in patients with HER2-positive gastroesophageal adenocarcinoma (GEA).2 The open-label, dose-escalation and -expansion study explored the use of 15 mg...