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European Approval in Breast Cancer, Orphan Drug Designation in AML, and More

Gina Columbus
Published Online: Friday, Aug 25, 2017



Today-

A European approval in breast cancer, an orphan drug designation in acute myeloid leukemia, encouraging results in a palliative care trial, intriguing findings in genetic testing for breast and ovarian cancer, and an FDA campaign announcement on e-cigarette use.

Welcome to OncLive News Network! I’m Gina Columbus.

The European Commission has granted approval to the CDK 4/6 inhibitor ribociclib in combination with any aromatase inhibitor as a first-line treatment for postmenopausal patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer.

The decision stems from a positive opinion given by the Committee for Medicinal Products for Human Use. It was based on findings of the phase III MONALEESA-2 trial, in which the combination of ribociclib plus letrozole was found to reduce the risk of disease progression or death by 43% versus letrozole alone.

Additionally, the combination led to a median progression-free survival of 25.3 months versus 16.0 months of patients who received letrozole monotherapy.

This marks the first approval of a CDK 4/6 inhibitor in Europe based on a first-line phase III trial that met its primary endpoint of PFS. Ribociclib was also granted approval by the FDA in March 2017 as a treatment for patients with metatstatic breast cancer.

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The FDA has granted SY-1425 an orphan drug designation for the treatment of patients with acute myeloid leukemia.

SY-1425 is an oral first-in-class selective retinoic acid receptor alpha agonist. The agent is currently being explored in a phase II trial of select subsets of patients with AML as well as myelodysplastic syndrome.

The ongoing study is assessing the safety and efficacy of SY-1425 as a single agent in 4 AML and MDS patient populations, as well as in combination with azacitidine, a standard-of-care regimen, in newly diagnosed patients with AML who are not appropriate candidates for standard chemotherapy.

All patients enrolled on the trial are prospectively selected using biomarkers for high expression of RARA or IRF8.

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States.

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Results of a population-based study have shown that palliative care can substantially decrease healthcare utilization in patients with advanced cancers.

The study found that this type of care among Medicare beneficiares in the SEER database resulted in less intensive care being delivered in end of life. This included lower rates of hospitalization, fewer invasive procedures, and reduced administration of chemotherapy at the end of life. It was also associated with higher rates of hospice enrollment and stays.

The effect of palliative care was examined among 6580 patients with advanced cancers of the prostate, breast, lung, or colon by comparing healthcare utilization before and after a palliative care consultation to a matched non-palliative care cohort. Specific findings showed that, in the palliative care group, they were 54% less likely to receive chemotherapy, 35% less likely to start a new chemotherapy regimen, and 24% more likely to enroll in hospice care.

While less intensive end-of-life healthcare utilization has been an area of previous research, this study is the first to show a relationship between palliative care and end-of-life care in the United States at a population-based level. 

*************************************

In breast and ovarian cancer, more than 80% of the 1.5 million patients who are at high risk for carrying select genetic mutations have not taken a genetic test nor discussed it with their physician, according to findings of a study published in the Journal of Clinical Oncology.

The mutations, including BRCA1 and BRCA2, could increase these patients’ risk for additional malignancies in the future. Of the 47,218 women whose records were reviewed, 2.7% had breast cancer. Among those who met study criteria, only 15.3% had taken a genetic test.

Additionally, 0.4% in the survey had ovarian cancer, but only 10.5% of them had underwent a genetic test. Based on these findings, researchers estimated that 1.2 to 1.3 million patients in the United States who would be most likely to benefit from genetic testing have not taken it.

Potential reasons the researchers said that so few patients have undergone the test include the ever-changing NCCN guidelines, as well as the relatively small number of board-certified genetic counselors who specialize in cancer testing.

*****************************************

The FDA has announced a new public health education campaign aimed at discouraging the use of e-cigarettes and electronic nicotine delivery systems by children.

This program, which is an expansion on its “The Real Cost” public education campaign, will encompass messaging towards teenagers regarding the risks associated with these products. These efforts are part of the agency’s new comprehensive plan for tobacco and nicotine regulation, as well as ongoing efforts to educate youth about, and protect them from, the hazards associated with using all tobacco products. It is the first time the FDA will be utilizing public health education to specifically target youth use of e-cigarettes or other ENDS.

Starting this fall, the FDA will be releasing new digital materials that are targeted to youth and focused on ENDS. This will include online videos to educate teenagers about the risks linked with using e-cigarettes or other ENDS.

Among the messages that will be part of the campaign is the potential for nicotine to rewire a teenager’s brain and create cravings that can lead to addiction.

The full-scale campaign is expected to launch in 2018.

********************************

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
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Today-

A European approval in breast cancer, an orphan drug designation in acute myeloid leukemia, encouraging results in a palliative care trial, intriguing findings in genetic testing for breast and ovarian cancer, and an FDA campaign announcement on e-cigarette use.

Welcome to OncLive News Network! I’m Gina Columbus.

The European Commission has granted approval to the CDK 4/6 inhibitor ribociclib in combination with any aromatase inhibitor as a first-line treatment for postmenopausal patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer.

The decision stems from a positive opinion given by the Committee for Medicinal Products for Human Use. It was based on findings of the phase III MONALEESA-2 trial, in which the combination of ribociclib plus letrozole was found to reduce the risk of disease progression or death by 43% versus letrozole alone.

Additionally, the combination led to a median progression-free survival of 25.3 months versus 16.0 months of patients who received letrozole monotherapy.

This marks the first approval of a CDK 4/6 inhibitor in Europe based on a first-line phase III trial that met its primary endpoint of PFS. Ribociclib was also granted approval by the FDA in March 2017 as a treatment for patients with metatstatic breast cancer.

*****************************************

The FDA has granted SY-1425 an orphan drug designation for the treatment of patients with acute myeloid leukemia.

SY-1425 is an oral first-in-class selective retinoic acid receptor alpha agonist. The agent is currently being explored in a phase II trial of select subsets of patients with AML as well as myelodysplastic syndrome.

The ongoing study is assessing the safety and efficacy of SY-1425 as a single agent in 4 AML and MDS patient populations, as well as in combination with azacitidine, a standard-of-care regimen, in newly diagnosed patients with AML who are not appropriate candidates for standard chemotherapy.

All patients enrolled on the trial are prospectively selected using biomarkers for high expression of RARA or IRF8.

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States.

**************************************

Results of a population-based study have shown that palliative care can substantially decrease healthcare utilization in patients with advanced cancers.

The study found that this type of care among Medicare beneficiares in the SEER database resulted in less intensive care being delivered in end of life. This included lower rates of hospitalization, fewer invasive procedures, and reduced administration of chemotherapy at the end of life. It was also associated with higher rates of hospice enrollment and stays.

The effect of palliative care was examined among 6580 patients with advanced cancers of the prostate, breast, lung, or colon by comparing healthcare utilization before and after a palliative care consultation to a matched non-palliative care cohort. Specific findings showed that, in the palliative care group, they were 54% less likely to receive chemotherapy, 35% less likely to start a new chemotherapy regimen, and 24% more likely to enroll in hospice care.

While less intensive end-of-life healthcare utilization has been an area of previous research, this study is the first to show a relationship between palliative care and end-of-life care in the United States at a population-based level. 

*************************************

In breast and ovarian cancer, more than 80% of the 1.5 million patients who are at high risk for carrying select genetic mutations have not taken a genetic test nor discussed it with their physician, according to findings of a study published in the Journal of Clinical Oncology.

The mutations, including BRCA1 and BRCA2, could increase these patients’ risk for additional malignancies in the future. Of the 47,218 women whose records were reviewed, 2.7% had breast cancer. Among those who met study criteria, only 15.3% had taken a genetic test.

Additionally, 0.4% in the survey had ovarian cancer, but only 10.5% of them had underwent a genetic test. Based on these findings, researchers estimated that 1.2 to 1.3 million patients in the United States who would be most likely to benefit from genetic testing have not taken it.

Potential reasons the researchers said that so few patients have undergone the test include the ever-changing NCCN guidelines, as well as the relatively small number of board-certified genetic counselors who specialize in cancer testing.

*****************************************

The FDA has announced a new public health education campaign aimed at discouraging the use of e-cigarettes and electronic nicotine delivery systems by children.

This program, which is an expansion on its “The Real Cost” public education campaign, will encompass messaging towards teenagers regarding the risks associated with these products. These efforts are part of the agency’s new comprehensive plan for tobacco and nicotine regulation, as well as ongoing efforts to educate youth about, and protect them from, the hazards associated with using all tobacco products. It is the first time the FDA will be utilizing public health education to specifically target youth use of e-cigarettes or other ENDS.

Starting this fall, the FDA will be releasing new digital materials that are targeted to youth and focused on ENDS. This will include online videos to educate teenagers about the risks linked with using e-cigarettes or other ENDS.

Among the messages that will be part of the campaign is the potential for nicotine to rewire a teenager’s brain and create cravings that can lead to addiction.

The full-scale campaign is expected to launch in 2018.

********************************

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
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