OBR Daily Commentary

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FDA Approves Amgen And Allergan's MVASI™ (bevacizumab-awwb) For The Treatment Of Five Types Of Cancer

(MarketWatch) Sept 14, 2017 - Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved MVASI™ (bevacizumab-awwb) for all eligible indications of the reference product, Avastin [®] (bevacizumab).

Howard S. Hochster, MD (Posted: September 15, 2017)

quotesFirst approval for a biosimilar in solid tumor usage! This should help bring down the cost of bev by about 1/3. Other bev biosimilars to follow. There is no approval for interchangeability with originator bev, and this must be prescribed specifically using the suffix. But this should be regarded as a step forward for patients and for control of costs. Ironically, Amgen took Novartis to the SCOTUS to delay their roll out of biosimilar filgrastim. Speak to your pharmacy committees!quotes

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Roche Presents Data From Global Phase III Study Showing Significant Clinical Benefit Of Alecensa (Alectinib) In Later-line Advanced ALK-Positive Lung Cancer

(Roche) Sep 6, 2017 - Roche today announced results from the global phase III ALUR study showing that Alecensa® significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 85% compared to chemotherapy in patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), who had progressed following treatment with platinum-based chemotherapy and crizotinib (hazard ratio [HR]=0.15, 95% CI: 0.08-0.29, p<0.001).

H. Jack West, MD (Posted: September 08, 2017)

quotesThe results of the ALUR trial are impressive but not surprising at all. We should expect a second generation ALK inhibitor to be superior to chemotherapy in crizotinib-pretreated ALK-positive patients. The difference is very striking and highly clinically significant in every efficacy endpoint. The efficacy of chemotherapy was rather disappointing overall. But this trial population should not exist for much longer. Today, with alectinib now becoming the first line therapy of choice for ALK-positive questions, the more relevant question is whether a subsequent alternative second generation ALK inhibitor, such as brigatinib, is a better choice than chemotherapy in alectinib-pretreated patients.quotes

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At $475,000, New Cancer Drug Raises Thorny Questions About Drug Pricing — And Value

(STAT/The Pharmalot View) Sept 4, 2017 - A first-of-its-kind cancer treatment is generating unbridled excitement — but also underscoring intense concerns over pricing and value.

Thomas Marsland, MD (Posted: September 05, 2017)

quotesWOW...that is a hunk of change...BUT it would appear that Novartis is at least following some of the suggestions in the recent ASCO paper on drug prices. They would appear to be looking at whether the drug works or not as part of the pricing. In addition they are also considering different pricing for different diseases with different efficacy and hence a somewhat different value proposition. Both approaches suggested in the ASCO report. With that said, $475,000 is still a heck of a lot of money. There is still very much a lack of transparency in how they came up with that number. It is interesting the market was predicting even higher pricing so this number makes them look good. They quote a billion dollars in investment but that is the number quoted for any new drug so why the huge pricing difference for this drug compared to other new innovative cancer therapies. Clearly Novartis has taken some steps toward better drug pricing but no question we still need to do better at controlling new drug costs (some old ones too...) quotes

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Meet the Editorial Board

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

Associate Cancer Center Director, Yale Cancer Center P...

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...