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Merck, AstraZeneca Stop Trial of Lynparza in Colorectal Cancer
An independent data monitoring committee made the recommendation to stop both arms of the trial after a planned interim analysis found the trial didn’t meet its objectives.
The phase 3 LYNK-003 trial investigating Lynparza (olaparib) with or without Genentech’s Avastin (bevacizumab) for the treatment of patients with metastatic colorectal cancer is being stopped for futility. Lynparza as a monotherapy and in combination with Avastin did not meet its objectives at a planned interim analysis. An independent data monitoring committee made the recommendation to discontinue both arms of the study. No new safety issues were seen, and the safety profile was similar to previous studies
Lynparza is a PARP inhibitor that is being co-developed and co-commercialized by Merck and AstraZeneca.
LYNK-003 is one of several trials that is a part of the Lynparza clinical development program. In addition to colorectal cancer, it is also being studied as both monotherapy and in new combinations across a range of DNA damage response deficient tumor types, including metastatic prostate cancer, ovarian cancer, breast cancer and pancreatic cancer.
Lynparza is approved for several indications, including advanced ovarian cancer, metastatic prostate cancer, metastatic pancreatic cancer, and early or metastatic breast cancer.
Using the 'Pathway' Approach to Shorten the Time Between Cancer Diagnosis and Treatment
November 16th 2022In this episode of Tuning In to the C-Suite, Briana Contreras, editor with Managed Healthcare Executive spoke with Dr. Yuri Fesko, oncologist and vice president of Medical Affairs at Quest Diagnostics. In the conversation, Dr. Fesko addressed the ongoing issue of long gaps of times between receiving a diagnosis for a type of cancer and finally getting the treatment for it. Dr. Fesko shared the benefits a number of sectors receive when treating patients sooner and the steps to get there.
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FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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