Today is celebrated World Breast Cancer Day, the most common carcinoma among women worldwide and the leading cause of mortality in this group. According to the World Health Organization (WHO), about one in 12 women will suffer from this type of cancer in their lifetime.
This year alone in Spain, according to data from the Spanish Society of Medical Oncology, there will be around 33,500 new cases of breast cancer
Although much progress has been made in its treatment – the chances of survival are 90% or more, especially when it is detected early – around 685,000 women died from this disease in 2020.
Only this year in Spain, according to data from the Spanish Society of Medical Oncology (SEOM), there will be about 33,500 new cases. Therefore, it is still necessary to search new therapies that help save lives.
A new treatment for triple negative
On October 15, the European Medicines Agency (EMA) reported about your recommendation to grant marketing authorization in the European Union (EU) of trodelvy (sacituzumab govitecan), a drug to treat adult patients with triple negative breast cancer that cannot be removed by surgery or that it is metastaticand who have received two or more prior systemic therapies, at least one of them for advanced disease.
Triple negative breast cancer is an aggressive type of cancer that lacks the usual receptors that other cancer drugs act on. Currently, the chemotherapy is the standard treatment.
It is estimated that only between 10 and 15% of people with triple negative breast cancer respond to chemotherapy and the time without the disease getting worse is only 2 to 3 months
However, it is estimated that only between 10 and 15% of people with this type of cancer respond to this treatment and the time without the disease getting worse is only 2 to 3 months. Therefore, there is a great medical need for new therapies that improve patient prospects.
The active substance in Trodelvy is satituzumab govitecan, which combines a humanized antibody – a type of protein – designed to recognize and bind to Trop-2 Receiver with a type of anticancer agent called topoisomerase I inhibitor. The goal is to inhibit the growth, division and spread of cancer.
The Committee on Medicines for Human Use (CHMP) of the EMA revised the application for marketing authorization to allow faster access of patients to this drug, through an accelerated deadline.
Greater survivability
The CHMP based its recommendation on data from a phase 3 clinical trial, multicentric, open and random. The study investigated the safety and efficacy of Trodelvy in 529 patients with locally advanced or metastatic triple negative breast cancer (mTNBC)
All enrolled patients relapsed after at least two previous chemotherapies for breast cancer. Participants were randomly assigned to receive satituzumab govitecan 10 mg/kg by intravenous infusion on days 1 and 8 of a 21-day cycle or a treatment of your choice (eribulin, vinorelbine, gemcitabine or capecitabine).
The drug prolonged overall survival by approximately 5 months and progression-free survival by approximately 3 months.
The prolonged drug general survival in approximately 5 months (11.8 months for sacituzumab govitecan compared to 6.9 months for the physician’s chosen treatment) and the progression free survival ─ life span without disease worsening – at about 3 months (4.8 months for sacituzumab govitecan compared to 1.7 months for the oncologist’s chosen therapy).
The most common side effects with Trodelvy in clinical trials were diarrhea, illness, neutropenia, fatigue, alopecia, anemia, vomiting, constipation, decreased appetite, cough and pain abdominal.
The advice adopted by the CHMP is only an intermediate step. This will be sent to the European Commission for decision on the authorization of its marketing throughout the EU. Once granted, each Member State will allocate the price and reimbursement based on the role or potential use of this medicine in the context of that country’s national healthcare system.
Source: EMA
Rights: Creative Commons.
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