OBR Daily Commentary

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Roche's Perjeta Regimen Approved In Europe For Use Before Surgery In Early Stage Aggressive Breast Cancer

(Roche) July 31, 2015 - The approval is based on the benefit seen with the Perjeta regimen in achieving pathological complete response (pCR) in the neoadjuvant (use before surgery) treatment of HER2-positive early breast cancer (eBC); this is the first approval in Europe based on pCR, a clinical endpoint that has allowed Perjeta to be made available to people with this aggressive disease faster.

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Debu Tripathy, MD (Posted: July 31, 2015)

quotesThis approval comes after US approval for the same indication and is noteworthy as the first drug approved under the new FDA pathway based on improved response to preoperative therapy. This rather unusual indication reflects more flexibility by regulatory agencies since this endpoint is associated with an improved longer term outcome (disease-free and overall survival). However, for full approval, it will be necessary to show that Perjeta does in fact improve long term outcome. It is hoped that success in the pre-operative setting can lead to a more rapid approval of a drug that does ultimately have a longer term and meaningful benefit.quotes

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Osteoporosis Drug Could Benefit Postmenopausal Women with Breast Cancer

(Cancer Research [UK]) July 23, 2015 - The study published in The Lancet, showed that the drugs – called bisphosphonates – reduced the risk of breast cancer coming back, as well as significantly reducing the risk of death, in women diagnosed after their menopause with early-stage breast cancer.

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Debu Tripathy, MD (Posted: July 28, 2015)

quotesBisphosphonates have been approved for a long time for osteoporosis and for cancer that has metastasized to the bone. In both cases, they lower the risk of fracture and other bone complications. Side effects are very rare, but can include atypical fractures of the femur, damage to the jawbone, and kidney dysfunction. Now, there is firm evidence for the analysis of multiple studies to show that these drugs, primarily represented by zoledronic acid (marketed by Novartis and Zometa), can improve survival, by about 3%, in postmenopausal women with early stage breast cancer. The individual trials have not all been positive – this is a rare case where it took a “meta-analysis” to clearly show the benefit. It remains to be seen if medical organizations and policy makers will declare this the new standard of care. Newer drugs such as RANK ligand inhibitors (eg. denosumab, marketed by Amgen as Prolia for osteoporosis and as XGEVA for bone metastases) as well as novel investigational drugs are in various phases of testing as “bone health” agents that could also improve longevity in cancer and may offer better benefit/risk ratios.quotes

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Meet the Editorial Board

Prostate Cancer
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Tomasz M. Beer, MD, FACP

Professor of Medicine, Division of Hematology/Medical O...

Community Oncology
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Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
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Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

Lung Cancer
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H. Jack West, MD

Medical Director, Thoracic Oncology Program, Swedish Ca...

Gastrointestinal Cancers
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Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

Radiation Oncology
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Howard Sandler, MD, MS, FASTRO

Ronald H. Bloom Chair in Cancer Therapeutics
Pr...

Community Oncology
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Jeff Patton, M.D.

CEO Tennessee Oncology...

Precision Medicine Section Editor
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Jennifer Levin Carter, MD, MPH

Chief Medical Officer and Founder, N-of-One...

Financial Sector
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Michael G. King Jr.

Managing Director and Senior Biotechnology Analyst...

Gastrointestinal Cancers
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Richard Goldberg, MD

Director WVU Cancer Institute Director of Cancer Signa...

Editor-In-Chief
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Robert A. Figlin, MD., FACP

Professor and Director, Division of Hematology Oncology...

Health Policy
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Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
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Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Community Oncology
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William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
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William McGivney, PhD

National Health Policy Expert...

Payer
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Winston Wong, PharmD

President, W-Squared Group...