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Gadavist de Bayer consigue cabeceo del FDA

por Lauren Dubinsky, Senior Reporter | June 12, 2014
Dennis Durmis
Bayer HealthCare announced today that its Gadavist Injection received FDA approval for intravenous use with MR of the breast to evaluate the presence and extent of breast cancer. It's the first and only MR contrast agent for this indication in the U.S.

It was first approved in the U.S. in March 2011 for intravenous use in diagnostic MR imaging for adults and children over two years old to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in the central nervous system.

"We have a couple of indications already for our agent but the breast indication is one that is certainly exciting for us," Dennis Durmis, head of the Americas region for Bayer's radiology and interventional business, told DOTmed News. "Breast cancer and breast cancer awareness continue to be a big trend for us and it seemed like a next logical place for us to continue to expand our indications."
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The approval was based on two multi-center Phase 3 studies called GEMMA-1 and GEMMA-2, which were conducted in 13 countries. The trials included 787 patients with recently diagnosed breast cancer, and for each study the MR images were analyzed by three independent radiologists.

They concluded that Gadavist-enhanced breast MR improved the ability to evaluate the presence and extent of breast cancer compared to images from non-enhanced breast MR. More specifically, breast MR with Gadavist had a sensitivity ranging from 80 to 89 percent, but without it there was 37 to 73 percent sensitivity.

Additionally, five out of six of the readers found that there was a true-negative rate of 80 percent for breasts without cancer.

However, the study did reveal that for breasts with malignancy, Gadavist overestimated the histologically confirmed extent of the malignancy in up to 50 percent of the patients. "A lot of it has to do with things such as the delivery of the agent and the interpretation of the exam results. "We believe that following the optimal guidelines that certainly can be reduced," said Durmis.

He also noted that mammography is often associated with false-positives. "I don't know if we're necessarily significantly different than the current offering, but what we can do is have a lot more improved diagnoses and improved visibility once the scan is done versus the standard of care today," he said.

The FDA approval process usually takes about 10 months but Bayer was able to get approval after just six months. "Certainly the FDA is supportive of the indication," said Durmis. "There is no other contrast agent out there that has this indication so it really was an unmet clinical need."

"At the end of the day, we're certainly hoping for more and better diagnoses," said Durmis. "This is a way for us to help raise awareness, help with diagnosis and ultimately, we hope for the improvement of women's lives as a result of a diagnosis."

The findings of the study will be presented at an upcoming medical meeting — Bayer is hoping to present the findings at this year's RSNA but they have not confirmed anything yet.

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