OBR Daily Commentary - Breast

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FDA Approves Pfizer's Trastuzumab Biosimilar, Trazimera

(The Center for Biosimilars) Mar 11, 2019 - The FDA has approved Pfizer’s trastuzumab-qyyp (Trazimera), a biosimilar referencing Herceptin. "This is an important milestone in the [United States] which both adds to our growing portfolio of oncology treatments and has the potential to improve access to cancer care,” said Andy Schmeltz, global president of Pfizer Oncology, in a statement. “We are proud to be able to offer treatment options that can help address the diverse needs of patients.”

Debu Tripathy, MD (Posted: March 12, 2019)

quotesWe will be seeing many more biosimilars approved in the coming years. This term is applied to biological agents since they are not precise chemical structures and therefore cannot be called "identical". By the same token, they may not possess completely equivalent clinical activity and safety. Regulatory agencies do not require the same rigor of testing as a new indication for a biologic agent, but they do have to show "similar" composition, activity and safety. Typically, the clinical endpoint may not have to be as robust (for example statistically non-inferior response as opposed to progression-free survival in the advanced setting, and complete pathological response pre-operatively as opposed to disease-free survival in the early stage setting). Nevertheless, it is general accepted (by some but not all), that these are similar enough to be substituted for the brand name. It is estimated that in the US, this may result in 30-40% drops in prices - maybe not the dramatic effect we would like to see in cancer drug prices, but outside of the US, they might make the difference between large numbers of patients receiving biological drugs vs. not.quotes

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FDA Grants Roche’s Tecentriq In Combination With Abraxane Accelerated Approval For People With PD-L1-positive, Metastatic Triple-Negative Breast Cancer

(Roche) Mar 11, 2019 - Roche today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumours express PD-L1, as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The FDA’s Accelerated Approval Programme allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition.

Debu Tripathy, MD (Posted: March 11, 2019)

quotesThis is a notable step forward in breast cancer therapeutics. Making advances, especially in survival, using immunotherapy has been a holy grail despite the long-held belief that the immune system is important in breast cancer when in fact, early immunotherapy trials using checkpoint inhibitors have been disappointing. However, the IMpassion130 trial is clearly positive - testing the addition of the anti PD-L1 antibody atezolizumab to nab-paclitaxel as first line therapy for PD-L1+ (in immune cells) triple negative breast cancer (TNBC). The indication does not specify line of therapy, but does specify the chemotherapy partner and need for PD-L1 testing. There will be a quick succession of results from additional trials - importantly, the KEYNOTE-355 trial testing the addition of pembrolizumab to one of three chemotherapy regimens also in the first line for TNBC is expected to report results later this year. Numerous randomized trials are ongoing (some preliminary already reported) in the neoadjuvant and adjuvant settings for all subsets of breast cancer. So expect an avalanche of data, but most importantly, more options for our patients that will hopefully make differences in survival and with some very long term responses.quotes

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FDA Alerts More Doctors Of Rare Cancer With Breast Implants

(Fox News/Associated Press) Feb 7, 2019 - U.S. health officials say doctors should be on the lookout for a rare cancer linked to breast implants after receiving more reports of the disease.

William McGivney, PhD (Posted: February 11, 2019)

quotesBreast Implants; Déjà Vu All Over Again Last week’s FDA warning regarding the association of breast implants with the occurrence (infrequent) of anaplastic large cell lymphoma (BIA-ALCL) focuses attention yet again on the implications of implanting a foreign object within the human body and the potential for immune system reaction to that object. This latest FDA warning reminds one of the issues raised during the early- to mid-1990s regarding an association of breast implants with the occurrence of autoimmune disease. The latest FDA warning raises a compelling issue for payers: “will payers cover the explanting of breast implants based upon a beneficiary’s concern about possible occurrence of ALCL?”. For payers, the issue revolves around conservative coverage policy regarding preventative services. Generally, private payers reimburse only for preventative services (e.g., mammography, colonoscopy) that are recommended in recognized national guidelines. If a payer views the explantation of breast implants as a preventative service it will likely deny the surgical intervention to remove the breast implant. If there is an actual medical condition (e.g., inflammation due to saline or silicone leakage), a payer may then view the surgical intervention as treatment and provide coverage. The other issue that arises above straight liability issues is: should manufacturers of breast implants be required to pay for the explantation of their breast implants. Twenty-five years ago, when the autoimmune issue arose, there were extensive business/financial conflicts within the major payers (e.g., Aetna, CIGNA) between the interests of the property casualty business within such companies and the health insurance side of the major insurance company. The property casualty components insured many of the breast implant manufacturers and thus were loath to the idea that their health insurer component might force manufacturers to pay. In essence, it would have been property and casualty side paying on behalf of the insured, the manufacturer. It is likely that this FDA warning will not receive the prolonged, highly visible attention given the breast implant-autoimmune disease association but many of the same coverage issues will resurface within the health insurers. 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...

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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...

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H. Jack West, MD

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National Health Policy Expert...

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