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The Ministry of Public Health and Social Welfare (MSPBS) recently approved the use of a new molecule called “Palbociclib,” in combination with the drugs letrozole, first-line, and fulvestrant, second-line or later.

For the treatment of postmenopausal women with advanced breast cancer, with positive hormone receptors, human epidermal growth factor receptor (HER2) negative 2, as initial endocrine therapy for their metastatic disease.

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Its approval represents a major breakthrough with respect to innovative therapies. The combination of letrozole with palbociclib (the new drug that is already available in our country) showed in studies Coloma-2 and Paloma-3 to double progression-free survival compared to those recorded in patients receiving hormone therapy as monodrug in these studies.

Also in the Paloma-2 it demonstrated to prolong in 40 months the time until the indication or the beginning of chemotherapy and in studies of the real world an increase in the global survival was observed. According to data from the Bulletin of Surveillance of Non-Communicable Diseases and Risk Factors of the Ministry of Health, in 2019 429 deaths from breast cancer and 1,747 new cases were registered in Paraguay.

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Therefore, it is estimated that between 30% and 40% of cases in which an early diagnosis was reached the disease will progress to advanced stages, i.e. those in which the tumor spread or migrated to others. tissues or organs of the body. Breast cancer is the most common type of cancer and represents the leading cause of cancer death in women in Paraguay and some Latin American countries.

In this sense, Dra. Cinthia Gauna, clinical oncologist, of the Medical Oncology Service of the Institute of Social Security (IPS) stressed “the arrival of palbociclib in Paraguay really means having a first-line drug in the management of the metastatic breast cancer, especially considering that it is the first of its kind (CDK4 / 6 inhibitors) approved in the country “.

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“Our therapeutic arsenal is now complete for this subgroup of patients in whom chemotherapy is not the right first-line therapy and hormone therapy with tamoxifen and aromatase inhibitors has been shown to have limited benefits.”

For her part, Dra. Valeria Cáceres, clinical oncologist, head of the Department of Clinical Oncology at the “Angel H. Roffo” Institute (UBA) in Buenos Aires, Argentina, said: “Of all cases of breast cancer that are diagnosed, close of 70% are responders to hormone therapy (positive RE) and 85 percent are HER 2 negative “.

“While of the group that are RE positive HER 2 negative, unfortunately about 30% will evolve at some point to locally advanced or metastatic stage, so that the universe of patients who could benefit from the approval of this new drug is very broad. “

It is the first and only drug approved in Paraguay of a new therapeutic class, of specific target, capable of selectively inhibiting cyclin-dependent kinases (CDKs) 4 and 6 to regain control of the cell cycle and block the proliferation of tumor cells.

And it should be noted that its availability in our country is encouraging news for the medical community and for all those patients who could benefit from its indication. Its approval was based on the results of the PALOMA-2 phase III study, conducted on 666 patients in 186 centers in 17 countries.

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The combination of the new drug and letrozole was generally well tolerated and the safety profile was predictable and manageable. The most common adverse events of the combination were neutropenia and leukopenia (decreased white blood cells) and fatigue.

Palbociclib has received accelerated review to be approved by the U.S. Food and Drug Administration (FDA) because preliminary evidence suggests that this medication could represent a substantial improvement for the treatment of this disease over the which was available at that time. He was also awarded the designation “Innovative Therapy”.