Piqray: Advanced HR+/HER2 Breast Cancer Novel Treatment.

In a significant development for advanced breast cancer treatment, Alpelisib Novartis received European Commission (EC) approval for Piqray (Alpelisib) in combination with Fulvestrant. This groundbreaking medication is the first and only targeted therapy specifically designed for patients with HR+/HER2- advanced breast cancer harboring a PIK3CA mutation, a genetic anomaly linked to poor treatment response.

The Significance of Piqray

Alpelisib tablets, commercially known as Piqray approval underscores Novartis commitment to advancing cancer care. This precision medicine aims to address a pressing need within the medical community by targeting advanced breast cancer associated with PIK3CA mutations. Each year, approximately 334,000 people worldwide are diagnosed with advanced breast cancer, and a substantial 40% of those with HR+/HER2- subtype carry this mutation, which has historically been challenging to treat.

The SOLAR-1 Phase III Trial

The EC’s approval of Piqray is rooted in the SOLAR-1 Phase III trial results, which demonstrated its efficacy. Piqray, combined with fulvestrant, almost doubled the median P

rogression-Free Survival (PFS) compared to fulvestrant monotherapy, with a PFS of 11.0 months versus 5.7 months. Moreover, the overall response rate significantly increased when Piqray was added to the treatment regimen.

A Personalized Approach

Piqray’s approval emphasizes the importance of personalized medicine in breast cancer treatment. It is crucial for patients with HR+/HER2- advanced breast cancer to undergo a validated test to detect the presence of a PIK3CA mutation in tumor or plasma specimens. This genetic information equips healthcare providers to develop a tailored treatment plan for each patient, offering hope for those facing a typically challenging prognosis. The available form of the medicine is tablet with the dosage of Piqray 150mg, 50mg and 200mg. 

Safety And Considerations

The most common side effects of Piqray (alpelisib) include rash, nausea, fatigue, decreased appetite, mouth sores, vomiting, hair loss, diarrhea, weight loss, and changes in certain blood tests. It’s essential to be aware of potential serious side effects, such as severe allergic reactions, severe skin reactions, high blood sugar levels, lung problems (pneumonitis), and diarrhea or colitis (inflammation of the intestines). Close monitoring and open communication with healthcare providers are crucial to manage these side effects effectively and ensure the safe use of Piqray in breast cancer treatment.

Warning And Precaution

Piqray, while a valuable treatment, comes with the potential for severe side effects. Patients must be aware of these risks, including severe hypersensitivity, severe cutaneous reactions (e.g., Stevens-Johnson syndrome), hyperglycemia, pneumonitis, and severe diarrhea. It’s crucial to promptly discontinue Piqray in the case of severe hypersensitivity and consult with a dermatologist if cutaneous reactions occur. 

Additionally, patients with diabetes should have their glucose levels optimized before and monitored during treatment. Respiratory symptoms should be watched for, and severe pneumonitis may necessitate treatment interruption. Severe diarrhea requires immediate attention, and adequate contraception is essential as Piqray can pose risks to fetal development. Patients should consult with their healthcare providers to manage these potential side effects effectively.

Fertility And Pregnancy Considerations

Piqray may have implications for fertility in both males and females. Therefore, women of childbearing potential should use effective contraception during and after treatment. Additionally, breastfeeding should be avoided after the last Piqray dose due to potential risks.

Conclusion

The approval of Piqray marks a crucial moment in treating HR+/HER2- advanced breast cancer with PIK3CA mutations. Novartis’ commitment to reimagining cancer care brings renewed hope for patients who typically face a challenging prognosis. The advent of precision medicine, exemplified by Piqray, represents a promising step forward in breast cancer treatment, emphasizing the power of tailored therapies to improve patient outcomes. Piqray cost in India depends on the product requirement. Request more details by contacting our Patient Support Team at ‎(+91) 9315705373 or help@sansfro.com. 

References: 

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212526s000lbl.pdf
2. https://www.novartis.com/news/media-releases/novartis-receives-piqray-approval-europe-first-and-only-targeted-medicine-hrher2-advanced-breast-cancer-pik3ca-mutation https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8749445/ 
3. https://canjhealthtechnol.ca/index.php/cjht/article/view/pc0247r/580