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Old 07-03-2019, 06:31 PM   #1
Lani
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Join Date: Mar 2006
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Thumbs up First PI3K Inhibitor for Breast Cancer approved by fda

News From the Food and Drug Administration

July 2, 2019
First PI3K Inhibitor for Breast Cancer


JAMA. 2019;322(1):19. doi:10.1001/jama.2019.8916


Alpelisib has received FDA approval for postmenopausal women, and men, with advanced or metastatic breast cancer whose tumors have a mutation in the PIK3CA gene. The drug is indicated for use in combination with the antiestrogen medication fulvestrant to treat hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (ERBB2)–negative tumors after endocrine-based therapy.
A companion diagnostic test to detect the PIK3CA mutation in a tissue sample and/or a liquid biopsy also received approval. Patients whose results are negative from the liquid biopsy test should undergo a tumor biopsy for PIK3CA mutation testing, according to the FDA.
“The ability to target treatment to a patient’s specific genetic mutation or biomarker is becoming increasingly common in cancer treatment, and companion diagnostic tests assist oncologists in selecting patients who may benefit from these targeted treatments,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a statement.
The PIK3CA gene encodes p110α, a catalytic subunit of phosphatidylinositol 3-kinase (PI3K), which is involved in cell growth and division. Alpelisib selectively inhibits p110α. In a clinical trial, 572 patients with advanced HR-positive, ERBB2-negative breast cancer that had progressed during or after aromatase inhibitor therapy were enrolled into either of 2 cohorts depending on their tumor mutation status (341 patients had confirmed PIK3CA mutations). Within each cohort, patients were randomized to receive alpelisib or placebo plus fulvestrant.
After a median treatment time of 20 weeks, progression-free survival among patients with PIK3CA mutations who received alpelisib and fulvestrant was 11 months compared with 5.7 months among those who received fulvestrant and placebo. Among patients without PIK3CA mutations, progression-free survival was 7.4 months in the alpelisib-fulvestrant group and 5.6 months in the placebo-fulvestrant group.
After 12 months, progression-free survival among patients with PIK3CA-mutated cancer was 46.3% in the alpelisib-fulvestrant group compared with 32.9% in the placebo-fulvestrant group. Among those without the mutation, progression-free survival at 12 months was 28.4% in the alpelisib-fulvestrant group and 22.2% in the placebo-fulvestrant group.
The most frequent adverse effects in the trial were hyperglycemia, diarrhea, nausea, decreased appetite, rash, and vomiting.
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Old 07-03-2019, 10:21 PM   #2
donocco
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Re: First PI3K Inhibitor for Breast Cancer approved by fda

Lani

Thanx for the info. The brand name of Alpelisib is PiqRay. I printed te FDA info and put it on the board tomorrow.
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Old 07-04-2019, 01:16 PM   #3
donocco
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Re: First PI3K Inhibitor for Breast Cancer approved by fda

Piqray (Alpelisib) is approved for Estrogen positive, Her 2 Neu negative postmenopausal
metastatic breast cancer. The dosage is 300mg (two 150mg capsules daily. If side effects become evident (they are common) the dosage can be reduced to 250mg daily and if this doesnt reduce the side effects the dosage can be lowered further to 200mg a day. The drug comes in 50mg, 100mg, and 150mg capsules. If the side effects are still severe at a dosage of 200mg daily, the drug should be discontiued.

Increases in blood sugar are very common and can be severe, as high as blood sugars
of 500mg percent. Antidiabetic drugs like Metformin, Actos and Januvia can be given to lower the blood sugar. Also the dosage of PiQray can be reduced. If the blood sugar doesnt drop to 160mg percent after 21 days, the drug is to be Dcd.

There can be severe diarrhea also. Any degree of diarrhea is very common, and the treatment is Imodium plus oral fluids. Once again the dosage can be lowered and if the problem continues, the drug should be discontinued.

Skin rashes are common and can progress to serious conditions like Steven Johnson Syndrome, so any kind of skin lesion has to be seriously watched.

Although rare, there can be Pneumonitis, so symptoms like cough and problems breathing have to be carefully monitired

Fatigue is very common as is nausea, loss of appetite, weight loss, stomatitis and hair loss. Usually the hair loss is not too severe.

There can be elevations of liver enzymes, decreased lymphocye count and loss of Calcium and Magesium.

Paul
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