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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 letrozole, first-line and fulvestrant, second-line or later.

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

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

Also, in Paloma-2, it has been shown to extend the time to the indication or start of chemotherapy by 40 months and in real world studies there has been an increase in overall survival.. According to data from the Bulletin for the Surveillance of Noncommunicable Diseases and Risk Factors of the Ministry of Health, in 2019 there were 429 deaths caused by breast cancer and 1,747 new cases in Paraguay.

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

In this regard, Dr. Cinthia Gauna, clinical oncologist at the Medical Oncology Service of the Institute of Social Security (IPS) stressed that “the arrival of palbocyclib in Paraguay really means having a first-line drug in the treatment of metastatic breast cancer, considering that it is the first of this type of drugs (CDK4 / 6 inhibitors) approved in the country ”.

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“Our therapeutic arsenal now seems 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 shown limited benefit.”

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

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

It is the first and only drug approved in Paraguay for a new therapeutic class, with a 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 side effects of the combination were neutropenia and leukopenia (decreased white blood cells) and fatigue.

Palbociclib received a rapid review for approval by the US Food and Drug Administration (FDA) because preliminary evidence shows that this drug could be a substantial improvement in the treatment of this disease compared to what was available at the time. In addition, it has been called “innovative therapy”.