FDA expands approved use of metastatic breast cancer treatment to include male patients

The U.S. Food and Drug Administration today is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.
Source: World Pharma News - Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

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A new study confirms that a CDK4/6 blocker plus endocrine therapy is better than chemotherapy in young women with HR+, HER2- metastatic disease.Medscape Medical News
Source: Medscape Medical News Headlines - Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
In a new study, patients with HR+/HER2- early stage breast cancer completed 2 years of adjuvant palbociclib with a similar toxicity profile as that observed in the metastatic setting.Annals of Oncology
Source: Medscape Today Headlines - Category: Consumer Health News Tags: Hematology-Oncology Journal Article Source Type: news
Condition:   Cancer Metastatic Interventions:   Drug: Paclitaxel injection;   Drug: Capecitabine tablets;   Drug: Letrozole 2.5mg;   Drug: Anastrozole 1mg;   Drug: Fulvestrant Prefilled Syringe;   Drug: Abemaciclib Sponsor:   UNICANCER Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conclusions: Despite encouraging pre-clinical evidence, there is a lack of clinical data to inform CNS-specific response rates to CDK4/6 inhibitors among patients with metastatic breast cancer. Given that the treatment of patients with breast cancer brain metastases represents an area of unmet medical need, enrollment of patients with CNS metastases in ongoing clinical trials should be encouraged; innovative trials that examine response of CNS metastases to CDK4/6 inhibitors are also of interest. PMID: 31695840 [PubMed]
Source: Oncotarget - Category: Cancer & Oncology Tags: Oncotarget Source Type: research
CONCLUSION: The DRP showed a potential in predicting fulvestrant treatment but was not significant in the overall analysis. Use of older biopsies, long-term endocrine treatment and multiple therapies between biopsy used for analysis and fulvestrant treatment, probably affect the predictive accuracy. PMID: 31654283 [PubMed - as supplied by publisher]
Source: Breast Cancer - Category: Cancer & Oncology Authors: Tags: Breast Cancer Source Type: research
CONCLUSIONS: LPBC was marginally associated with higher pCR rate than non-LPBC in LT treated HER2+ BC patients. Quantitative assessment of the immune infiltrate by m-IF is feasible and may help correlate individual immune cell subpopulations and immune cell profiles with treatment response. PMID: 31653641 [PubMed - as supplied by publisher]
Source: Clinical Cancer Research - Category: Cancer & Oncology Authors: Tags: Clin Cancer Res Source Type: research
CONCLUSION: HRQoL was maintained on abemaciclib plus fulvestrant. Alongside superior PFS and manageable safety profile, results support treatment with abemaciclib plus fulvestrant in a population of patients with endocrine-resistant HR+, HER2-negative ABC. IMPLICATIONS FOR PRACTICE: In MONARCH 2, abemaciclib plus fulvestrant demonstrated superior efficacy and a manageable safety profile for patients with in hormone receptor-positive (HR+), HER2-negative (-) advanced breast cancer (ABC). Impact on health-related quality of life (HRQoL) is important to consider, given the palliative nature of ABC treatment. In this stud...
Source: The Oncologist - Category: Cancer & Oncology Authors: Tags: Oncologist Source Type: research
This article summarizes FDA decision-making and data supporting the approval of palbociclib for the treatment of male patients with HR-positive, HER2-negative advanced or metastatic breast cancer. PMID: 31649043 [PubMed - as supplied by publisher]
Source: Clinical Cancer Research - Category: Cancer & Oncology Authors: Tags: Clin Cancer Res Source Type: research
Abstract PURPOSE: To test the validity of OncoMasTR Molecular Score (OMm), OMclin1 and OncoMasTR Risk Score (OMclin2) prognostic scores for prediction of distant recurrence (DR) in ER-positive/HER2-negative breast cancer treated with 5 years' endocrine therapy only and compare their performance with the Oncotype DX Recurrence Score (RS). EXPERIMENTAL DESIGN: OMm incorporates three Master Transcription Regulator genes. OMclin1 combines OMm, tumor size, grade, nodal status; OMclin2 incorporates OMm, tumor size, nodal status. OMclin1 and OMclin2 were evaluated for 646 postmenopausal patients with ER-positive/HER...
Source: Clinical Cancer Research - Category: Cancer & Oncology Authors: Tags: Clin Cancer Res Source Type: research
The combined use of a CDK4/6 inhibitor with endocrine therapy yielded a 9.4-month median OS benefit among patients.
Source: CancerNetwork - Category: Cancer & Oncology Authors: Source Type: news
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