- Center on Health Equity & Access
- Clinical
- Health Care Cost
- Health Care Delivery
- Insurance
- Policy
- Technology
- Value-Based Care
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.
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.
Listen
AI in Health Care: Closing the Revenue Cycle Gap
April 1st 2025This commentary explores the current state, challenges, and potential of artificial intelligence (AI) in health care revenue cycle management, emphasizing collaboration, data standardization, and targeted implementation to enhance adoption.
Read More
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.
Listen
FDA Approves Cabozantinib for Advanced Pancreatic Neuroendocrine Tumors
March 26th 2025With strong progression-free survival benefits demonstrated in the CABINET trial and updates to National Comprehensive Cancer Network guidelines, this approval reinforces cabozantinib’s role in improving outcomes for patients facing these challenging cancers.
Read More
