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FDA Approves Palbociclib for Metastatic Breast Cancer
The FDA has granted an accelerated approval to palbociclib (Ibrance) as a frontline treatment for postmenopausal women with estrogen receptor (ER)-positive, HER2-negative metastatic breast cancer, based on findings from the phase 2 PALOMA-1 trial.
In the open-label phase 2 study, treatment with letrozole plus the novel CDK 4/6 inhibitor palbociclib reduced the risk of disease progression by 51% compared with letrozole alone. The median progression-free survival (PFS) with palbociclib was 20.2 months versus 10.2 months for letrozole alone (Hazard ratio [HR] = 0.488; P = .0004).
Palbociclib was approved under the FDA’s Breakthrough Therapy designation and priority review program, which provides an expedited approval process for treatments that provide a substantial benefit over current options. The FDA was not scheduled to make a decision on the drug’s application until April 2015. “The addition of palbociclib to letrozole provides a novel treatment option to women diagnosed with metastatic breast cancer,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “The FDA is committed to expediting marketing approval of cancer drugs through our accelerated approval regulations.”
To read the article, visit OncLive.
Insurance Payer Is Associated With Length of Stay After Traumatic Brain Injury
February 21st 2025Among hospitalized patients with traumatic brain injury, Medicaid fee-for-service was associated with longer hospital stays than private insurance and Medicaid managed care organizations.
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Exploring Racial, Ethnic Disparities in Cancer Care Prior Authorization Decisions
October 24th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the October 2024 issue of The American Journal of Managed Care® that explored prior authorization decisions in cancer care by race and ethnicity for commercially insured patients.
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Managed Care Reflections: Insights From Richard J. Gilfillan, MD; and Donald M. Berwick, MD, MPP
February 20th 2025To mark the 30th anniversary of The American Journal of Managed Care (AJMC), each issue in 2025 includes reflections from a thought leader on what has changed over the past 3 decades and what’s next for managed care. The February issue features a retrospective by Richard J. Gilfillan, MD, former director of the Center for Medicare and Medicaid Innovation; and Donald M. Berwick, MD, MPP, former administrator of CMS.
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Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
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