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FDA Approves Bayer HealthCare (BAY)'s Gadavist (Gadobutrol) Injection As The First Magnetic Resonance Contrast Agent For Evaluation Of Breast Cancer In The United States


6/12/2014 8:18:19 AM

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- Gadavist-enhanced breast MRI demonstrated superior sensitivity (range: 80-89%) for the presence and extent of malignant disease compared to unenhanced breast MRI (range: 37-73%)

- Sensitivity for the presence and extent of malignant breast disease ranged from 68-73% with x-ray mammography

- Findings of pivotal studies consistent with clinical guidelines recommending the use of contrast-enhanced breast MRI in patients with newly diagnosed breast cancer

WHIPPANY, N.J., June 12, 2014 /PRNewswire/ -- Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Gadavist® (gadobutrol) injection for intravenous use with MRI of the breast to assess the presence and extent of malignant breast disease. The approval is based on priority review of two, multi-center, Phase 3 studies (GEMMA-1 and GEMMA-2) conducted in 13 countries.

"The Phase 3 GEMMA studies demonstrate that Gadavist-enhanced breast MRI provided a statistically significant improvement in the identification of the extent of breast cancer versus unenhanced MRI," said GEMMA Principal Investigator Gillian Newstead, M.D., F.A.C.R., from the University of Chicago Medical Center. "This is an important diagnostic tool for healthcare professionals with breast cancer patients. Breast MRI with Gadavist provides important visibility for assessment of malignant breast disease and for treatment planning."

"While we've made great strides in the US with early detection, one in five women will still have undetected breast cancer following a mammogram," said Dennis Durmis, Head of the Americas Region for Bayer's Radiology & Interventional business. "The FDA's swift action in approving Gadavist for contrast enhanced breast MRI is consistent with recent guidelines from cancer and breast imaging societies."

About the GEMMA Studies

Two, multi-center, Phase 3 clinical trials with identical design (GEMMA-1 and GEMMA-2) were used to investigate the diagnostic efficacy of Gadavist-enhanced breast MRI. In total, 787 patients with recently diagnosed breast cancer from 13 countries were enrolled (GEMMA-1: 390 women; GEMMA-2: 396 women and one man). In each study, MRI images were analyzed by three independent radiologists. These readers confirmed that Gadavist-enhanced breast MRI improved ability to assess the presence and extent of breast cancer when compared to images from unenhanced breast MRI.

Key findings for these studies included:

  • Gadavist-enhanced breast MRI demonstrated superior sensitivity (range: 80-89%) for the presence and extent of malignant disease compared to unenhanced breast MRI (range: 37-73%) for all six readers.
  • A true-negative rate (specificity) of >80% for breasts without malignant disease was confirmed for Gadavist-enhanced breast MRI by 5 of 6 readers.

The studies did reveal that in breasts with malignancy, Gadavist-enhanced breast MRI overestimated the histologically confirmed extent of malignancy in the diseased breast in up to 50% of the patients.

Three additional radiologists in each study read x-ray mammography alone. For these readers, over both studies, sensitivity for the presence and extent of malignancy ranged from 68% to 73% and specificity ranged from 86% to 94% in non-malignant breasts.

Final study findings will be presented at an upcoming medical meeting.

About Breast Cancer and its Detection

Breast cancer is the most common cancer among women in the developed world and has an increasing prevalence. It is second only to lung cancer in terms of cancer death in women and is the leading cause of death for Hispanic women in the US. About 40,000 women in the US died of the disease in 2013.

About Gadavist

Gadavist® (gadobutrol) injection was first approved in the US in March 2011 for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.

Gadavist, also known as Gadovist® and Gadovist 1.0® in other regions, is the United States (US) brand name of the aqueous solution of gadobutrol, a gadolinium (Gd)-based extracellular contrast agent for magnetic resonance imaging (MRI).

IMPORTANT SAFETY INFORMATION

WARNING: Nephrogenic Systemic Fibrosis (NSF)

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.

The risk of NSF appears highest among patients with: Chronic, severe kidney disease (GFR <30 mL/min/1.73m2), or Acute kidney injury.

Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.

For patients at highest risk for NSF, do not exceed the recommended GADAVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.

Contraindication and Important Information about Hypersensitivity Reactions: Gadavist® is contraindicated in patients with history of severe hypersensitivity reactions to Gadavist®. Anaphylactoid and anaphylactic reactions with cardiovascular, respiratory, or cutaneous manifestations, ranging from mild to severe, including death, have uncommonly occurred following Gadavist® administration. Patients with any history of a reaction to contrast media, bronchial asthma, and/or allergic disorders may have an increased risk for a hypersensitivity reaction to Gadavist®.

Acute Kidney Injury: In patients with chronic renal impairment, acute kidney injury sometimes requiring dialysis has been observed with the use of some GBCAs. Do not exceed the recommended dose; the risk of acute kidney injury may increase with higher than recommended doses.

Extravasation and Injection Site Reactions: Ensure catheter and venous patency before the injection of Gadavist®. Extravasation into tissues during Gadavist® administration may result in moderate irritation. Avoid intramuscular administration of Gadavist®.

Overestimation of Extent of Malignant Disease in MRI of the Breast:

Gadavist MRI of the breast overestimated the histologically confirmed extent of malignancy in the diseased breast in up to 50% of the patients.

Adverse Reactions: The most frequent (0.5%) adverse reactions associated with Gadavist® in clinical studies were headache (1.5%), nausea (1.2%), injection site reaction (0.6%), dysgeusia (0.5%) and feeling hot (0.5%).

Please see full prescribing information at http://labeling.bayerhealthcare.com/html/products/pi/gadavist_PI.pdf.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries. More information at www.healthcare.bayer.com.

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Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

US Lit Code: 325-28-0001-14 June 2014

SOURCE Bayer HealthCare

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