Doctor Healthy: Tyverb is back in Europe

Tyverb is back in Europe The European Commission has referred GlaxoSmithKline Plc’s breast cancer treatment Tyverb back for a fresh assessment by drugs regulators following new data from Europe’s biggest pharmaceuticals company.

Glaxo said on Tuesday that Tyverb, which is already on sale in the United States under the name Tykerb, had been referred back to the EU’s Committee for Medicinal Products for Human Use (CHMP) for further discussion.

It said the new information was from a standard pharmacovigilance review of clinical trial and post-marketing data.

Glaxo’s Tyverb Referred for More Discussion in Europe

GlaxoSmithKline Plc’s Tyverb breast cancer drug was sent back to a European regulatory panel after new data showed the medicine may raise the risk of liver damage, slowing final approval.

The European Commission returned the application to the region’s health-care regulator for further discussion, probably during its April 21-24 meeting, London-based Glaxo said today in an e-mailed statement. An agency committee recommended approval of Tyverb following a review in December.

Tyverb is one of the medicines Glaxo is relying on to help counter slowing growth in sales of its top-selling asthma drug Advair and diabetes pill Avandia and the loss of patent protection on other products. The commission was expected to issue a final decision on the breast cancer drug between Feb. 22 and March 8, Glaxo said.

“It’s not particularly good news,” analyst Nick Turner of Mirabaud Securities in London said in a telephone interview. “This is a drug that promised much but isn’t likely to deliver.”

The new data showed signs that the medicine can raise the level of liver enzymes in patients, a possible warning sign for damage to the organ. Elevated liver enzymes were seen in four out of 1,000 patients, and “generally returned to normal” after they stopped using the drug, according to the U.K. company.

Positive Profile

“GSK believes these data do not change the positive benefit-risk profile for Tyverb in the proposed indication,” Glaxo said in the statement.

Glaxo shares rose 38 pence, or 3.7 percent, to close at 1,054 pence in London trading.

The European Medicines Agency said in December that it recommended conditional approval of Tyverb for breast cancer that has advanced or spread to other parts of the body in patients with the HER-2 gene, which makes the disease more aggressive. Conditional approval is valid for one year while the company obtains more information about the medicine and its effectiveness, EMEA said at the time.

First aid

First aid is a complicated subject and it is situation-specific. First aid is the help and medical assistance that someone gives, not only to an injured person, but to a person who is sick. Preparedness is a key element of first aid, like having basic medical emergency kits in your home, car, boat, or RV. It is also advised to be prepared for illness while traveling locally or to a foreign country. Cuts, puncture wounds, sprains, strains, nosebleeds are one type of injury that may require first aid; heart attacks, strokes, seizures, and heat stroke are examples of more critical first aid emergencies.

Making Decisions About Cancer Treatment

fter a diagnosis of cancer, patients and their families must make a number of decisions about cancer treatment, some of which are more difficult than others. These decisions are complicated by unfamiliar words, various statistics, and a sense of urgency. However, it is important to allow time to research your options and ask questions. Decisions about cancer treatment are personal, and it is important that you feel comfortable about your decisions.

Learn about your cancer. Try to understand as much as you can about your cancer, such as its stage (a way of describing a cancer, such as where it is located and if it has spread to other parts of the body). The Cancer.Net Guides to Cancer are a good place to begin. If you are unfamiliar with certain words, ask your doctor or nurse or use a medical dictionary. Some people find it helpful to take notes during a doctor’s visit or bring a friend along to help keep track of all the information.

Know your options. Talk with your doctor about treatment options for your type and stage of cancer. Some of these options may include surgery, radiation therapy, chemotherapy, hormone therapy, active surveillance (watchful waiting), enrolling in a clinical trial, and not receiving treatment. People are often surprised to learn that they may have different treatment options.

Understand the goals of treatment. Often, cancer can be cured with treatment, called curative treatment. However, there are times when treatment is only used to relieve side effects, such as pain, and this is called palliative treatment. Knowing the goals of treatment helps people evaluate which risks are acceptable. For example, people who know their treatment is curative may be more willing to face potentially unpleasant side effects.

Learn about the risks and benefits of each treatment option. Different treatments have different risks, as well as potential side effects. An important part of making a decision is weighing the positives and negatives of each treatment option, including your ability to manage the side effects that are more common for the specific type of treatment. Factors to consider include the likelihood that the cancer will recur (come back) after treatment, the chances of living longer with or without treatment, the possibility of side effects, and your personal and family preferences.

Obtain a second opinion. Many people find that it helps to get a second or even third opinion from another oncologist and many doctors encourage it. Different oncologists may have different experiences with various treatments, and seeking multiple opinions may help you make a decision. Read more about types of oncologists. Also, learn more about seeking a second opinion.

Consult guidelines or other decision-making tools. Many cancer organizations, such as the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN), publish guidelines and treatment decision-making tools to help doctors and people with cancer understand various treatment options. One example is a decision aid tool developed by ASCO and Cancer Care Ontario for people with non-small cell lung cancer. Some cancer centers offer sophisticated statistical tools you can use with your doctor to help determine the best treatment option based on your personal medical information. Always use treatment guidelines and other programs with the help and interpretation of your doctor. Learn more about ASCO’s Patient Guides.

Talk about your decision with people you trust. Talk to your family, friends, a member of the clergy or spiritual advisor, an oncology social worker, and other people with cancer. What you decide is ultimately up to you, but some people find it helpful to talk through their concerns with other people. Many patient support organizations bring together people who have coped with similar experiences.

The role of statistics

Your doctor will probably mention many statistics when describing treatment options, including relative survival rates, disease-free survival rates, and progression-free survival rates. These numbers may be a good way to learn about how the treatment options differ, but they can’t predict how well the treatment will work in an individual. Your doctor can help you understand how these statistics relate to your treatment. Learn more about cancer statistics.

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Tyverb is back in Europe

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