The researches find that the tablets were approve for the treatment of hormone receptor (HR)-positive; therefore human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutate; because advance or metastatic breast cancer in combination with fulvestrant; the U.S. Food and Drug Administration announced Friday.
Metastatic breast cancer
The tablets are approve for use in men and postmenopausal women whose disease progress after treatment with an endocrine-based regimen. The drug is also approve in combination with a companion diagnostic test; the thera screen PIK3CA RGQ PCR Kit; which detects the PIK3CA mutation in a tissue or liquid biopsy. The recommend dose of Piqray is 300 mg (two 150-mg tablets) once daily; according to the manufacturer’s prescribing information.
Approval was based on data from the SOLAR-1 trial, which included 572 men and postmenopausal women with HR-positive; HER2-negative; advanced or metastatic breast cancer that progress with an aromatase inhibitor. Among patients whose tumors had a PIK3CA mutation; median progression-free survival was 11 months for those treated with the combination of Piqray and fulvestrant compared with 5.7 months in patients treated with fulvestrant alone.
The overall response rate is 35.7 versus 16.2% for patients treat with Piqray and fulvestrant versus those treat with fulvestrant alone. Clinicians should monitor patients who are taking Piqray for severe hypersensitivity reactions and should warn patients of potentially severe skin reactions. Piqray is contraindicated in patients with a history of severe skin reactions like Stevens-Johnson syndrome, erythema multiforme, or toxic epidermal necrolysis.
Because patients taking Piqray have report severe hyperglycemia, clinicians check patients’ fasting glucose and hemoglobin A1c and optimize glycemic control. Severe cases of pneumonitis/interstitial lung disease and diarrhea have also been reported with Piqray; clinicians are advise to monitor patients for these conditions during treatment.
Lung disease and diarrhea
Approval of Piqray was granted to Novartis, and approval of the therascreen PIK3CA RGQ PCR Kit is grant to QIAGEN Manchester Ltd.Breast cancer cells take out during a biopsy or surgery will be tested to see if they have certain proteins that are estrogen or progesterone receptors. When the hormones estrogen and progesterone attach to these receptors, they fuel the cancer growth.
Cancers are call hormone receptor-positive or hormone receptor-negative base on whether or not they have these receptors (proteins). Knowing the hormone receptor status is important in deciding treatment options. Receptors are proteins in or on cells that can attach to certain substances in the blood. Normal breast cells and some breast cancer cells have receptors that attach to the hormones estrogen and progesterone, and depend on these hormones to grow.