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FDA has approved Piqray, the first PI3K inhibitor for HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer

The FDA ( U.S. Food and Drug Administration ) has approved Piqray ( Alpelisib ) tablets, to be used in combination with the FDA-approved endocrine therapy Fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer ( as detected by an FDA-approved test ) following progression on or after an endocrine-based regimen.

The FDA also approved the companion diagnostic test, therascreen PIK3CA RGQ PCR Kit, to detect the PIK3CA mutation in a tissue and/or a liquid biopsy.
Patients who are negative by the therascreen test using the liquid biopsy should undergo tumor biopsy for PIK3CA mutation testing.

The efficacy of Piqray was studied in the SOLAR-1 trial, a randomized trial of 572 postmenopausal women and men with HR-positive, HER2-negative, advanced or metastatic breast cancer whose cancer had progressed while on or after receiving an aromatase inhibitor.
Results from the trial showed the addition of Piqray to Fulvestrant significantly prolonged progression- free survival ( median of 11 months vs. 5.7 months ) in patients whose tumors had a PIK3CA mutation.

Common side effects of Piqray are high blood sugar levels, increase in creatinine, diarrhea, rash, decrease in lymphocyte count in the blood, elevated liver enzymes, nausea, fatigue, low red blood cell count, increase in lipase, decreased appetite, stomatitis, vomiting, weight loss, low calcium levels, aPTT prolonged, and hair loss.

Health care professionals are advised to monitor patients taking Piqray for severe hypersensitivity reactions ( intolerance ).
Patients are warned of potentially severe skin reactions ( rashes that may result in peeling and blistering of skin or mucous membranes like the lips and gums ).
Health care professionals are advised not to initiate treatment in patients with a history of severe skin reactions such as Stevens-Johnson syndrome, erythema multiforme, or toxic epidermal necrolysis.
Patients on Piqray have reported severe hyperglycemia, and the safety of Piqray in patients with type 1 or uncontrolled type 2 diabetes has not been established.
Before initiating treatment with Piqray, health care professionals are advised to check fasting glucose and HbA1c, and to optimize glycemic control.
Patients should be monitored for pneumonitis / interstitial lung disease ( inflammation of lung tissue ) and diarrhea during treatment.

Piqray must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

Piqray is the first new drug application ( NDA ) for a new molecular entity approved under the Real-Time Oncology Review ( RTOR ) pilot program, which permits the FDA to begin analyzing key efficacy and safety datasets prior to the official submission of an application, allowing the review team to begin their review and communicate with the applicant earlier. ( Xagena )

Source: FDA, 2019