FDA

FDA Approves Nexavar for Advanced Thyroid Cancer

The US Food and Drug Administration (FDA) have approved Nexavar (sorafenib) to treat some people with advanced thyroid cancer. The drug was already on the market for treating some types of kidney cancer and liver cancer. The new approval is for treating differentiated thyroid cancer – the most common type – that has come back after treatment or that has spread to other parts of the body (metastasized), and is no longer responding to radioactive iodine treatment.

Thyroid cancer starts in the thyroid gland, which is located in the front part of the neck. Nexavar is a targeted therapy that can help stop the growth of cancer cells by interfering with signals that encourage them to grow. Nexavar qualified for faster review under the FDA’s priority review program for drugs that may offer a significant improvement in safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. The drug also received orphan-product designation by the FDA because it is intended to treat a rare disease or condition.

“Differentiated thyroid cancer can be challenging to treat, especially when unresponsive to conventional therapies,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a prepared statement. “Today’s approval demonstrates the FDA’s commitment to expediting the availability of treatment options for patients with difficult-to-treat diseases.”

The FDA based its approval on a clinical study involving 417 people with advanced, differentiated thyroid cancer that was not responding to radioactive iodine treatment. Nexavar increased the length of time patients lived without the cancer growing by 41%. Half the people who received Nexavar lived without the cancer growing for at least 10.8 months compared to at least 5.8 months for those who received a placebo.

The most common side effects for Nexavar were diarrhea, fatigue, infection, hair loss, skin problems on the hands and feet, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, and high blood pressure. Thyroid stimulating hormone is more likely to become elevated while on treatment with Nexavar, requiring adjustment of thyroid hormone therapy.

Nexavar is co-marketed by Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals.

US FDA issues import alert for Ranbaxy drugs

The US Food and Drug Administration on Monday issued an import alert against drug products manufactured at Indian drug major Ranbaxy’s facility in Punjab’s Mohali for non-compliance with US drug manufacturing requirements.

Under the import alert which will stand until the company complies with what are known as current good manufacturing practices (CGMP), US officials may detain at the US border drug products manufactured at the Mohali facility, the US regulator said in a media release.

“We want American consumers to be confident that the drugs they are taking are of the highest quality, and the FDA will continue to work to prevent potentially unsafe products from entering the country,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Centre for Drug Evaluation and Research.

The US drug regulator also ordered that the Mohali facility be subject to certain terms of the consent decree of permanent injunction entered against Ranbaxy in January 2012.

The decree contains provisions to ensure CGMP compliance at certain Ranbaxy facilities, including in Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh, as well as provisions addressing data integrity issues at those two facilities.

Ranbaxy’s Paonta Sahib and Dewas facilities have been on FDA import alert since 2008.

In September and December 2012, FDA inspections identified significant CGMP violations at Ranbaxy’s Mohali facility, including failure to adequately investigate manufacturing problems and failure to establish adequate procedures to ensure manufacturing quality, the FDA release said.

Under the decree, Ranbaxy is required to hire a third-party expert to conduct a thorough inspection of the Mohali facility and certify to the FDA that the facilities, methods, processes, and controls are adequate to ensure continuous compliance with CGMP.

Once the agency is satisfied that Ranbaxy has come into compliance with CGMP, Ranbaxy will be permitted to resume manufacturing and distribution of FDA-regulated drugs at the Mohali facility, the FDA said. [IANS]

Source: India Medical Times

New technology makes breast cancer surgery more precise

FDA approved MarginProbe in December 2012, and UC Irvine Medical Centre is the first hospital in the US to employ the system

Any breast cancer surgeon who regularly performs lumpectomies confronts the question “Did I get it all?” Thirty to 60 per cent of the time in the US, the answer is “no,” requiring the patient to undergo a second surgery to remove the remaining tumor.

Surgeons at UC Irvine Medical Centre are the first in the country to use a device that reduces by half the need to re operate and cut out breast cancer cells missed during an initial lumpectomy. The Margin Probe System lets the surgeon immediately assess whether cancer cells remain on the margins of excised tissue. Currently, patients have to wait days for a pathologist to determine this.

“All of my patients know someone who has had to go back into surgery because their doctor didn’t get the entire tumor out,” said UC Irvine Health surgical oncologist Dr Alice Police. “The ability to check tissue in the operating room is a game changer in surgery for early-stage breast cancer.”

The goal in a lumpectomy is to completely remove the cancer while preserving as much normal breast tissue as possible. If a pathologist finds cancer cells on the edges of the tissue taken out, surgeons must assume the lumpectomy didn’t get the entire tumor.

The Food and Drug Administration (FDA) approved MarginProbe in December 2012, and UC Irvine Medical Centre is the first hospital in the US to employ the system, according to manufacturer Dune Medical Devices.

Dr Police, assistant professor of surgery at UC Irvine and medical director of Pacific Breast Care in Costa Mesa, and Dr Karen Lane, associate professor of surgery and clinical director of the UC Irvine Health Breast Health Centre in Orange, began operating with MarginProbe in early March.

They had participated in an FDA trial that included more than 660 women across the US. In the prospective, multicentre, randomized, double-arm study, surgeons applied the device to breast tissue removed during in-progress initial lumpectomies and, if indicated, shaved additional tissue on the spot. This was found to reduce by 56 per cent the need for repeat surgeries.

“It will save you a lot of anxiety,” said Jane Madigan, a Costa Mesa resident who underwent the procedure with Dr Police as part of the MarginProbe trial. “You will come out of that surgery knowing you are cancer-free.”

The system comprises a sterile handheld probe and a portable console. When the probe tip touches an excised lumpectomy specimen, radio-frequency signals are transmitted into the tissue and reflected back to the console, where they are analyzed using a specialized algorithm to determine tissue status.

Source: http://www.indiamedicaltimes.com/2013/06/06/new-technology-makes-breast-cancer-surgery-more-precise/