Publications by authors named "D C Auth"
Article Synopsis
- On September 2, 2022, the FDA approved durvalumab, and on October 31, 2023, pembrolizumab, both in combination with cisplatin and gemcitabine, for treating unresectable or metastatic biliary tract cancers (BTC).
- The approvals were based on two clinical trials (TOPAZ-1 for durvalumab and KEYNOTE-966 for pembrolizumab), which showed significant improvements in overall survival when these drugs were added to standard chemotherapy compared to placebo.
- Both treatments had safety profiles consistent with existing knowledge and did not show new adverse event signals, providing more options for patients with advanced BTC.
Article Synopsis
- On November 8, 2023, the FDA approved fruquintinib, a drug targeting VEGFR receptors, for treating patients with metastatic colorectal cancer (mCRC) who have undergone specific prior therapies.
- The approval was based on the results from the FRESCO-2 trial, which showed that patients taking fruquintinib had a statistically significant improvement in overall survival compared to those on a placebo.
- Fruquintinib demonstrated a median overall survival of 7.4 months versus 4.8 months for placebo, with side effects consistent with the known safety profile of VEGFR inhibitors.
On January 19, 2023, the FDA granted accelerated approval to tucatinib in combination with trastuzumab for the treatment of patients with unresectable or metastatic RAS wild-type, HER2-positive colorectal cancer who have received prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan. Approval was based on the pooled analysis of patients receiving tucatinib in combination with trastuzumab in MOUNTAINEER (NCT03043313), an open-label, multicenter trial. The primary endpoint was overall response rate (ORR) by RECIST 1.
View Article and Find Full Text PDFOn September 30, 2022, the FDA granted accelerated approval to futibatinib for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) with FGFR2 fusions or other rearrangements. Approval was based on Study TAS-120-101, a multicenter open-label, single-arm trial. Patients received futibatinib 20-mg orally once daily.
View Article and Find Full Text PDFGlobal adoption of risk management principles outlined in the International Conference on Harmonisation (ICH) E2E guideline and the Council for International Organizations of Medical Sciences (CIOMS) Working Group VI guidance introduced greater proactivity and consistency into the practice of pharmacovigilance and benefit-risk management throughout the lifecycle of a drug. However, following the release of these guidelines there have been important advances in the science and practice of risk minimisation itself, especially in terms of how risk minimisation measures (RMMs) are designed, implemented, disseminated and evaluated for effectiveness in real-world healthcare settings. In this article, we describe how the field of design, implementation, dissemination and evaluation of RMMs has advanced in recent years while highlighting current areas of challenge and possible solutions.
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