FDA Grants Approval for Truqap (capivasertib) in Combination with Faslodex as Treatment for Advanced HR-Positive Breast Cancer Patients

The Food and Drug Administration (FDA) has recently granted approval for a new treatment option for advanced hormone receptor-positive (HR-positive) breast cancer patients. The combination of Truqap (capivasertib) and Faslodex has shown promising results in clinical trials, offering hope to those affected by this aggressive form of breast cancer.

HR-positive breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all cases. This type of cancer is characterized by the presence of hormone receptors, specifically estrogen and progesterone receptors, on the surface of cancer cells. These receptors allow the cancer cells to grow and divide in response to hormone stimulation.

While there have been significant advancements in the treatment of HR-positive breast cancer over the years, there is still a need for more effective therapies, especially for patients with advanced disease. Truqap, developed by pharmaceutical company AstraZeneca, is a novel oral drug that targets a protein called AKT, which plays a crucial role in promoting cancer cell growth and survival.

The FDA’s approval of Truqap in combination with Faslodex is based on the results of the FAKTION clinical trial. This Phase II trial involved 140 postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had previously received endocrine therapy. The participants were randomly assigned to receive either Truqap plus Faslodex or a placebo plus Faslodex.

The trial demonstrated that the combination of Truqap and Faslodex significantly improved progression-free survival compared to Faslodex alone. Progression-free survival refers to the length of time during which the disease does not worsen. The median progression-free survival for patients receiving the combination therapy was 10.3 months, compared to 4.8 months for those receiving Faslodex alone.

Furthermore, the combination therapy also showed a favorable safety profile, with manageable side effects. The most common adverse events reported in the trial included diarrhea, fatigue, and nausea. These side effects were generally mild to moderate in severity and could be effectively managed with supportive care.

The approval of Truqap in combination with Faslodex provides a new treatment option for HR-positive breast cancer patients who have progressed on or after endocrine therapy. This combination therapy offers a targeted approach to inhibit the AKT pathway, which is often dysregulated in HR-positive breast cancer.

Dr. José Baselga, Executive Vice President of Oncology R&D at AstraZeneca, expressed his excitement about the FDA’s approval, stating, “We are delighted that the FDA has approved Truqap in combination with Faslodex, providing a new treatment option for patients with advanced HR-positive breast cancer. This approval represents an important milestone in our ongoing commitment to advancing the treatment landscape for patients with breast cancer.”

The approval of Truqap in combination with Faslodex is a significant step forward in the fight against advanced HR-positive breast cancer. It offers hope to patients who have exhausted other treatment options and provides oncologists with a valuable tool to improve patient outcomes. As further research and clinical trials continue to explore the potential of combination therapies, we can expect more advancements in the treatment of this challenging disease.