Treatment of breast cancer Novartic PI3K inhibitors approved by the European Union.

On July 29th, Novart announced that the European Commission (EC) had approved The alpelisib to be used in combination with fulvestrant for post-menopenerine women and men with breast cancer.
These patients tested positive for hormones (HR plus), human epithet growth factors were negative (HER-), and progression continued after a single endocrine therapy, carrying PIC3CA mutations and local late stage or metastasis.
Piqray is the first and only approved drug specifically targeted at patients with PIC3CA mutant breast cancer.
approval is based on positive comments made by the European Medicines Agency (EMA) Committee on Human Pharmaceutical Products (CHMP) on the application at the end of May this year.
CHMP and EC are both based on phase III clinical trials of SOLAR-1.
The study was conducted in a randomized, double-blind, placebo-controlled study that assessed the efficacy and safety of Piqray's combined treatment with fluoxetic group therapy in post-menopathic women and male patients with PY2-advanced or metastasis breast cancer during or after treatment with or after treatment with aromatase inhibitors (a CDK4/6 inhibitor).
a total of 572 patients were involved in a 1:1 ratio of randomly receiving Piqray (300 mg, once a day) and fluorovis groups (500 mg, one cycle every 28 days, one intensive injection on the 15th day of the first cycle), or placebos and fluoravis groups.
results showed that Piqray combined fluorovis groups nearly doubled the mid-PFS (11.0 months vs. vs. 5.7 months), the risk of death was significantly reduced by 35% (HR-0.65, 95% CI: 0.50-0.85; p.001), and the overall mitigation rate was more than 2 times (36% vs.16%).
adverse events in this study were mild to moderate and were usually controllable through dose adjustment and medical management.
, 70 percent of breast cancer patients are HR-/HER-, of which about 40 percent have PIC3CA activation mutations.
Piqray is an oral small molecule alpha-specific PI3K inhibitor that inhibits tumor cell proliferation by inhibiting pi3K signaling path paths.
who use Piqray should pass genetic testing on tumor or plasma samples to confirm the carrying of PIC3CA mutations.
if plasma testing does not show the mutation, if feasible, tumor tissue should be further tested for confirmation.
the drug was approved by the FDA in May 2019 and is the first FDA-approved PI3K alpha inhibitor for breast cancer treatment.
In China, on April 27 this year, alpelisib was approved clinically in China, and the combined fluorovis group therapy was used in endocrine therapy or after treatment of hormone-positive, HER2-negative, PIK3CA mutations in women with advanced breast cancer (post-menovascular) and male patients.
two PI3K alpha inhibitors have been approved worldwide, the other being Bayer's copanlisib, which was approved in 2017 for the treatment of fig-lymphoma.
source: Novartis receives Piqray® approval in Europe - the first and only targeted medicine for HR plus/HER2- advanced breast cancer with a PIK3CA mutation.