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Merck's PD-1 Inhibitor May be Approved Earlier Than Anticipated
Pembrolizumab was expected to be approved by October, but the turnaround might be much earlier.
U.S. regulators are likely to approve Merck & Co's highly anticipated immuno-oncology drug, pembrolizumab, as a treatment for melanoma well ahead of a late October deadline, according to three sources familiar with the situation.
If approved by the Food and Drug Administration, the drug would be the first in a promising new class designed to help the body's own immune system fend off cancer by blocking a protein known as Programmed Death receptor (PD-1), or a related target known as PD-L1, used by tumors to evade disease-fighting cells.
Companies including Bristol-Myers Squibb, Roche Holding AG and AstraZeneca Plc are racing to develop similar treatments for a variety of cancers. Some analysts expect the new class could generate more than $30 billion in annual sales worldwide by 2025.
The FDA is slated to decide on New Jersey-based Merck's application no later than October 28, but sources said the agency could give its approval within coming weeks. The sources, who spoke on condition of anonymity because they were not authorized to discuss the FDA's plans, also acknowledged that the early approval was not guaranteed.
Read the complete report here: http://reut.rs/1l8l05r
Source: Reuters
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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Uniting to Support Patients With Cancer Beyond Treatment
November 17th 2024Kasey Bond, MPH, of Perlmutter Cancer Center at NYU Langone Health, speaks to why it’s vital to keep patients at the center of all strategic partnerships between academic institutions and community-based oncology practices.
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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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Bridging Cancer Care Gaps and Overcoming Medical Mistrust
November 13th 2024In this clip from our interview with Oscar B. Lahoud, MD, cochair of our Institute for Value-Based Medicine® evening hosted with NYU Langone Health, he addressed medical mistrust in underrepresented communities.
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How English- and Spanish-Preferring Patients With Cancer Decide on Emergency Care
November 13th 2024Care delivery innovations to help patients with cancer avoid emergency department visits are underused. The authors interviewed English- and Spanish-preferring patients at 2 diverse health systems to understand why.
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