Piqray was launched on May 24, 2019.
When Was Piqray Launched?
The launch of Piqray (alpelisib) in the United States officially occurred on May 24, 2019, coinciding with its approval by the Food and Drug Administration (FDA). This approval marked a significant milestone, making Piqray available for patients with a specific type of advanced breast cancer.
What is Piqray?
Piqray, with the generic name alpelisib, is an oral medication manufactured by Novartis Pharmaceuticals Corporation. It is designed to target a particular genetic mutation common in breast cancer, offering a new treatment pathway for eligible patients.
Key Details of Piqray's Approval
Piqray's approval was a targeted therapy specifically indicated for a subset of breast cancer patients. Below are the key details surrounding its launch:
| Aspect | Detail |
|---|---|
| Launch/Approval Date | May 24, 2019 |
| Generic Name | Alpelisib |
| Brand Name | Piqray |
| Manufacturer | Novartis Pharmaceuticals Corporation |
| Approved Indication | In combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer. |
| Regulatory Body | Food and Drug Administration (FDA) |
Significance of Piqray's Launch
The approval and subsequent launch of Piqray were significant for several reasons:
- Targeted Therapy: It provides a targeted treatment option for patients whose breast cancer has a specific PIK3CA gene mutation, which is often associated with tumor growth and resistance to endocrine therapy.
- Specific Patient Population: The drug's approval addresses a critical need for advanced or metastatic breast cancer in patients who are hormone receptor (HR)-positive and HER2-negative, expanding their treatment choices.
- Combination Therapy: Its use in combination with fulvestrant highlights the evolving strategies in cancer treatment, focusing on synergistic effects to improve patient outcomes.
For more detailed information regarding Piqray's approval and its clinical context, you can refer to resources from the Food and Drug Administration (FDA).
