Anvisa approves medicine for more common type of breast cancer

The Pfizer just announced the approval of the National Health Surveillance Agency (Anvisa) for the Ibrance drug (palbociclib), an innovative therapy for the treatment of women with advanced breast cancer type estrogen receptor positive (ER +) and HER2. That is, they are patients with tumors that grow in response to the estrogen hormone and are not related to HER2 protein. For over 10 years there has been no mention of an innovative first-line treatment for this type of cancer, which accounts for the majority of cases of breast tumors.

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Because it represents a major breakthrough in breast cancer treatment and is a unique therapeutic alternative in settings with no other options, Ibrance has been included in the Food and Drug Administration (FDA) priority review list as early as 2014, receiving approval soon after United States, in February 2015, two months ahead of schedule. The drug has also been licensed in the European Union since 2016.

“The approval of Ibrance represents a very important step for the Brazilian women, as a way to bring them closer to an innovative therapy that has been widely used in other countries,” says Pfizer’s medical director, Eurico Correia. “If in the past the perspectives were limited for these women, today we can think of a scenario of disease control and maintenance of quality of life, even when the diagnosis occurs at an advanced stage, a situation that is common in Brazil.”

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Ibrance is indicated in combination with the drug letrozole as first-line treatment for postmenopausal women who have not received prior systemic treatment for advanced stage disease and in combination with fulvestrant as a second line for pre or postmenopausal women with breast cancer the disease has progressed during or after endocrine therapy.


Early diagnosis is important to reduce the risk of metastasis in women with breast cancer, but up to 30% of patients develop with disease progression and metastasis even though the disease has been detected early1, which highlights the importance of therapeutic options able to meet this medical need and benefit patients.

Ibrance is an oral target agent that selectively inhibits cyclin-dependent kinases (CDK4 and CDK6), which makes it possible to regain control of the cell cycle and block the proliferation of tumor cells. The drug also represents continued Pfizer investments in the development of breast cancer treatments, a work started with Aromasin, a medication approved in the United States in 2007, and in Brazil in 2009.

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Clinical Studies

Efficacy and safety data for palbociclib were collected from a broad clinical development program consisting of robust studies: PALOMA-1, which served as the basis for accelerated adoption of Ibrance by the FDA in 2015, in addition to PALOMA-2 and PALOMA-3.

About breast cancer

Breast cancer is the most common type of tumor among women, both in Brazil and in the world, accounting for 22% of new cases of cancer in the country each year, according to the National Cancer Institute (INCA). In developing countries such as Brazil, a greater number of patients are diagnosed at an advanced stage. The most updated INCA data on this problem is from 2013 when 14,388 people died in the country because of the disease. In Latin America, every year, 150,000 new cases of metastatic breast cancer are diagnosed, of which more than 40,000 evolve to death

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