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Amgen's T-Vec to Receive FDA Decision Today
The vaccine, approved in Europe last week, is now awaiting approval in the United States.
Imlygic, or talimogene laherparepvec, a genetically modified herpes simplex type 1 virus developed by Amgen to be injected directly into tumors, where it replicates and forces tumor cell rupture, is waiting for FDA's decision. The NDA for this virus-based treatment has been submitted for melanoma.
An advisory panel for the FDA reviewed data from the phase 3 OPTiM trial and voted 22-1 in favor of approval back in April 2015. Now the FDA has to consider this panel's advice before it's decision later today.
Meanwhile, the European Medical Agency approved T-Vec for use in patients with unresectable melanoma that has not metastatized just last week.
Read more here.
Survey Results Reveal Potential Factors Slowing the Decline in Cardiovascular Mortality Rate
April 23rd 2024Research indicated that worsened glycemic, blood pressure, and obesity control, as well as increased alcohol consumption, leveled lipid control, and persistent socioeconomic disparities may have contributed to the decelerated cardiovascular mortality decline in recent years.
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Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
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Patient-Reported Outcomes Help to Uncover Frailty Patterns in Those With Acute COPD Exacerbations
April 22nd 2024Study findings demonstrate the pivotal role of patient-reported outcomes in identifying frailty among individuals experiencing acute exacerbations of chronic obstructive pulmonary disease (COPD).
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