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Heavy pound! Pfizer breakthrough breast cancer drug Ibrance was approved by the FDA line extended to the second line treatment of HR+/HER2- breast cancer

Source:http://www.wisdomdrugs.com Tssuing time:2016-03-25

The American pharmaceutical giant Pfizer (PFE) breakthrough breast cancer drug Ibrance (AACR, 125 mg capsule) recently awarded the FDA approved a wider indications, combined with AstraZeneca medical oncology Faslodex (fulvestrant, fluorine dimension our group) for received endocrine therapy after disease progression of hormone receptor positive (HR +), human epidermal growth factor receptor negative in 2 (HER2) advanced or metastatic breast cancer female patients treatment.
Ibrance is the first CDK4/6 inhibitor in the world market. Before Ibrance have been in February 2015 received accelerated approval by the FDA, joint Femara (letrozole, letrozole) for first-line treatment have not received prior systemic therapy to control post advanced disease in postmenopausal women HR+/HER2- advanced or metastatic breast cancer. Among them, Femara is the drug of Novartis oncology.
The expanded indication approved, also marked the Ibrance HR+/HER2- breast cancer treatment success by first-line treatment extended to second-line treatment, will significantly expand the Ibrance group of patients.
Business outlook is also very optimistic about the Ibrance industry. Earlier, the global pharmaceutical industry research firm GlobalData released a report pointed out that the HR + breast cancer will be dominated by Pfizer CDK4 / 6 inhibitor Ibrance, 2023 sales will reach $18.5 billion, and AstraZeneca PARP inhibitors Lynparza will leading triple negative breast cancer (TNBC) market. (report: 2023 global HER2 negative breast cancer treatment market will reach $6 billion 100 million)
It is worth mentioning that the 2 combinations of Ibrance program are all obtained by the United States National Comprehensive Cancer Network (NCCN) recommended. Among them, Ibrance+Femara (HR+/HER2-) combination therapy as a class 2A (2A Category) recommended for postmenopausal women with metastatic breast cancer first-line treatment of metastatic breast cancer. Ibrance+Faslodex (fulvestrant) combination therapy as class 1 (Category 1) recommended for the accepted endocrine therapy but progression of the disease in postmenopausal women HR+/HER2- metastasis of breast cancer treatment, as well as for undergoing ovarian suppression by luteinizing hormone releasing hormone LHRH agonist) in postmenopausal women HR+/HER2- transfer of breast cancer treatment.
The expansion of indications approved, is based on data from the key phase PALOMA-3 III clinical study, the study involved 521 cases of breast cancer patients, investigate the clinical potential of Ibrance second line treatment of breast cancer. In this study, Ibrance was combined with Faslodex (fulvestrant, f), for the treatment of patients with metastatic breast cancer who were receiving or have received endocrine therapy but had a worse condition. Data show that compared with the treatment group Faslodex, Ibrance+Faslodex in combined treatment group progression free survival was significantly prolonged (4.6 month median PFS:9.5 months vs, P < 0.0001), confirm the total remission rate was increased significantly (24.6% vs. 10.9%) and remission duration is prolonged (9.3 months vs 7.6 months).
About Ibrance:
Ibrance is the first to target an oral CDK4/6 inhibitor, can selectively inhibit cyclin dependent kinase 4 and 6 (CDK4/6), recovery of cell cycle control, inhibition of tumor cell proliferation. Cell cycle control is a hallmark of cancer, CDK4/6 was overactive in many cancers, leading to uncontrolled cell proliferation. CDK4/6 is a key regulator of cell cycle, can trigger cell cycle from the growth stage (stage G1) copy to DNA (S1) change. In estrogen receptor positive (ER+) breast cancer, overactive CDK4/6 very frequently, while CDK4/6 is a key downstream target of ER signal. Preclinical data suggest that dual inhibition of CDK4/6 and ER signals have a synergistic effect, and G1 can inhibit the growth of breast cancer cells ER+.


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