OBR Daily Commentary

forumImage

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.”

Read Article arrow

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

Add Comment 1 Comment
forumImage

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.

Read Article arrow

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

Add Comment 1 Comment
forumImage

Making Cancer Clinical Trials Available to More Patients

(NCI/Cancer Currents Blog) Mar 7, 2019 - Over the past several years, NCI has made efforts to address the issue of trial eligibility by working to broaden the criteria for some NCI-funded trials.

Read Article arrow

Debu Tripathy, MD (Posted: March 09, 2019)

quotesCriteria for clinical trials sometimes occupy several pages of a protocol, underscoring how selective they can be by excluding certain age groups, or those with decreased organ function. While some of these may be important for safety reasons, many times they are overly burdensome, especially for when they are intended for patients with refractory cancers who might be expected to have some limitations or physiologic abnormalities. When a new drug is approved, we are finding that the studies upon which the approval was based are so stringent in their eligibility, that "real-world" cohorts or registries must be studied, adding cost and delays in our understanding to true benefit and risk balance of a drug. Efforts to make trials more streamlined and reflective of the target population are welcome.quotes

Add Comment 1 Comment

Meet the Editorial Board

Prostate Cancer
member photo
Tomasz M. Beer, MD, FACP

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

Community Oncology
member photo
Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
member photo
Debu Tripathy, MD

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

Lung Cancer
member photo
H. Jack West, MD

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

Gastrointestinal Cancers
member photo
Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

Radiation Oncology
member photo
Howard Sandler, MD, MS, FASTRO

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

Community Oncology
member photo
Jeff Patton, M.D.

CEO Tennessee Oncology...

Precision Medicine Section Editor
member photo
Jennifer Levin Carter, MD, MPH

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

Financial Sector
member photo
Michael G. King Jr.

Managing Director and Senior Biotechnology Analyst...

Gastrointestinal Cancers
member photo
Richard Goldberg, MD

Director WVU Cancer Institute Director of Cancer Signa...

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

Professor and Director, Division of Hematology Oncology...

Health Policy
member photo
Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
member photo
Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Community Oncology
member photo
William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
member photo
William McGivney, PhD

National Health Policy Expert...

Payer
member photo
Winston Wong, PharmD

President, W-Squared Group...