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Breakthrough Therapy Designation for Aduro's Immunooncology Combination for Pancreatic Cancer
Aduro joins the exclusive group of companies, so far only the big pharma, that have a successful trail of immunooncology candidates.
Aduro BioTech joined the short list companies outside Big Pharma to pick up the FDA's coveted breakthrough therapy designation, impressing the agency with strong mid-stage results for its combo cancer therapy.
An FDA breakthrough tag entitles Aduro to a speedy review and access to senior agency staff as it works through the regulatory process with CRS-207 and GVAX, two immunotherapies designed to battle pancreatic cancer in tandem.
The regulatory victory comes on the heels of positive Phase II data for the combination, in which Aduro's cocktail beat out GVAX alone in 93 patients with metastatic pancreatic cancer. Median overall survival on the combo came in at 6.1 months, a statistically significant improvement over GVAX's 3.9 months.
Now Aduro is working through an expanded Phase IIb trial, enrolling about 240 patients into three treatment arms: one receiving the combination treatment, one taking CRS-207 alone and another on standard chemotherapy. The study's primary endpoint is overall survival, and Aduro hopes it'll back up the safety, immune response and efficacy CRS-207 and GVAX have demonstrated thus far.
Read the report here: http://bit.ly/1rjxxDm
Source: FierceBiotech
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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