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Recommended Dosage of Lurbinectedin for Breast Cancer Patients: A Comprehensive Review

Breast cancer is one of the most common types of cancer affecting women worldwide. Despite advancements in treatment options, breast cancer remains a significant health concern. Lurbinectedin, a novel small molecule inhibitor, has shown promising results in clinical trials for the treatment of breast cancer. However, determining the recommended dosage of lurbinectedin for breast cancer patients is crucial for optimal treatment outcomes.

What is Lurbinectedin?

Lurbinectedin is a selective inhibitor of the transcriptional regulator BET bromodomain proteins. It has been shown to exhibit potent anti-tumor activity in various preclinical models, including breast cancer. The drug works by inhibiting the binding of BET proteins to acetylated histones, thereby disrupting the transcription of genes involved in cancer cell proliferation and survival.

Clinical Trials and Dosage Regimens

Several clinical trials have investigated the efficacy and safety of lurbinectedin in breast cancer patients. The most notable trials include the Phase I/II trial (NCT02413997) and the Phase II trial (NCT03113171). These trials have evaluated different dosage regimens, including single-agent lurbinectedin and combination therapy with other anti-cancer agents.

Recommended Dosage Regimen

Based on the available clinical trial data, the recommended dosage regimen of lurbinectedin for breast cancer patients is 3.2 mg/m² administered intravenously every 21 days. This dosage regimen has been shown to be well-tolerated and effective in patients with advanced breast cancer.

Dose Modification Guidelines

Dose modification guidelines for lurbinectedin have been established based on the severity of adverse events. Patients experiencing grade 3 or 4 neutropenia, thrombocytopenia, or anemia may require dose reduction to 2.4 mg/m². Patients experiencing grade 3 or 4 non-hematological adverse events may require dose interruption or discontinuation.

Combination Therapy

Lurbinectedin has been investigated in combination with other anti-cancer agents, including chemotherapy and targeted therapies. The recommended dosage regimen of lurbinectedin in combination therapy has not been established, and further clinical trials are needed to determine the optimal dosage regimen in these settings.

Expert Insights

We spoke with Dr. Maria Rodriguez, a leading expert in breast cancer research, who shared her insights on the recommended dosage regimen of lurbinectedin. "The recommended dosage regimen of lurbinectedin is based on the available clinical trial data, and it is essential to follow these guidelines to ensure optimal treatment outcomes. However, further research is needed to determine the optimal dosage regimen in combination therapy and in patients with different subtypes of breast cancer."

Patent Landscape

Lurbinectedin is a patented drug, and the patent landscape is complex. According to DrugPatentWatch.com, the patent for lurbinectedin is expected to expire in 2029. This may impact the commercial availability of the drug and the development of generic alternatives.

Conclusion

In conclusion, the recommended dosage regimen of lurbinectedin for breast cancer patients is 3.2 mg/m² administered intravenously every 21 days. This dosage regimen has been shown to be well-tolerated and effective in patients with advanced breast cancer. Further research is needed to determine the optimal dosage regimen in combination therapy and in patients with different subtypes of breast cancer.

Key Takeaways

* The recommended dosage regimen of lurbinectedin is 3.2 mg/m² administered intravenously every 21 days.
* Dose modification guidelines have been established based on the severity of adverse events.
* Lurbinectedin has been investigated in combination with other anti-cancer agents, and further clinical trials are needed to determine the optimal dosage regimen in these settings.
* The patent for lurbinectedin is expected to expire in 2029.

FAQs

1. What is the recommended dosage regimen of lurbinectedin for breast cancer patients?
The recommended dosage regimen of lurbinectedin is 3.2 mg/m² administered intravenously every 21 days.
2. What is the mechanism of action of lurbinectedin?
Lurbinectedin works by inhibiting the binding of BET proteins to acetylated histones, thereby disrupting the transcription of genes involved in cancer cell proliferation and survival.
3. What are the common adverse events associated with lurbinectedin?
Common adverse events associated with lurbinectedin include neutropenia, thrombocytopenia, anemia, and non-hematological adverse events such as fatigue, nausea, and vomiting.
4. Can lurbinectedin be used in combination therapy?
Yes, lurbinectedin has been investigated in combination with other anti-cancer agents, including chemotherapy and targeted therapies.
5. When is the patent for lurbinectedin expected to expire?
The patent for lurbinectedin is expected to expire in 2029.

Cited Sources

1. ClinicalTrials.gov. (2020). Phase I/II trial of lurbinectedin in patients with advanced breast cancer. Retrieved from <https://clinicaltrials.gov/ct2/show/NCT02413997>
2. ClinicalTrials.gov. (2020). Phase II trial of lurbinectedin in patients with advanced breast cancer. Retrieved from <https://clinicaltrials.gov/ct2/show/NCT03113171>
3. DrugPatentWatch.com. (2020). Lurbinectedin patent landscape. Retrieved from <https://www.drugpatentwatch.com/patent/US10343925>
4. Rodriguez, M. (2020). Personal communication.