Results for 'trastuzumab'
Mark Verrill, Paul Declerck, Sibylle Loibl, Jake Lee & Javier Cortes
The rise of oncology biosimilars: from process to promise
biologic, biosimilar, breast cancer, SB3, trastuzumab
Biosimilars are biologic products that are highly similar to the approved originator molecule, with no clinically meaningful differences. They are expected to play a key role in cancer treatment by reducing costs and improving access. Regulatory bodies use robust mechanisms for approval, involvi…
Aug 23rd • 18 mins read
Gregory S. Calip, PharmD, MPH, PhD, Ivy P. Altomare, MD, Jenny S. Guadamuz, MSPH, PhD
Evaluating External Validity of Oncology Biosimilar Safety Studies
biologics, external validity, FDA, biosimilars, trastuzumab
Biologics are the fastest growing medication class in the US, significantly contributing to healthcare costs. The Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway to make biological products more accessible. A phase 3 randomized trial of SB3, a trast…
Apr 6th • 2 mins read
Carina Dolan, PharmD, BCOP
Opportunities and challenges in biosimilar uptake in oncology
Trastuzumab, Rituximab, biosimiliar agents, emerging agents, cetuximab, bevacizumab, clinical trials, biosimiliars
The U.S. has 10 approved biosimilars, including 3 for oncology, with many more in development, potentially increasing access to expensive biologics. Acceptance by healthcare providers and patients requires extensive education, resolving concerns about immunogenicity, and ensuring interchangeability.…
Jun 26th • 7 mins read
iNIZIO
Transforming oncology: Five frontiers driving progress in cancer care
From biomarker-driven breakthroughs to AI-powered early detection and a renewed commitment to equity and patient centricity, the past 12 months have seen major strides across cancer research, treatment, and communication. At Inizio, we’ve had a front-row seat to this transformation, supporting…
May 16th • 5 mins read
Ali Raza Khaki
Loose Regulatory Standards Portend a New Era of Imprecision Oncology
precision oncology, TMB-high, homologous recombination deficiency, Olaparib, pembrolizumab
Precision oncology aims to tailor cancer treatment based on genetic understanding, revolutionizing oncology. The FDA has been approving drugs under precision oncology with broad indications that may not align with studied populations. Examples include the approval of pembrolizumab for a wide ran…
Dec 1st • 4 mins read
Sonoko Kawakatsu, René Bruno, Matts Kågedal, Chunze Li, Sandhya Girish, Amita Joshi, Benjamin Wu
Confounding factors in exposure–response analyses and mitigation strategies for monoclonal antibodies in oncology
monoclonal antibodies, E-R analyses, tumour growth inhibition, drug development
Dose selection and optimization is crucial in drug development to maximize benefits for all patients. Exposure–response (E-R) analysis is useful for dose-selection strategy, but in oncology, prognostic factors can confound the analysis, especially for monoclonal antibodies. The review addr…
Nov 20th • 12 mins read
E.M. Ray, L.A. Carey, K.E. Reeder-Hayes
Leveraging existing data to contextualize phase II clinical trial findings in oncology
HER2, phase II trials, oncology, iDFS, EBC, early stage breast cancer
In the USA, over 250,000 women are diagnosed with early-stage breast cancer (EBC) yearly, with up to 30% having HER2 amplification. The standard care for HER2-positive EBC involves chemotherapy plus HER2-directed therapy for one year. The phase II Adjuvant Paclitaxel and Trastuzumab (APT) tr…
Sep 21st • 3 mins read
Laleh Amiri-Kordestani & Richard Pazdur
Oncology approvals in 2020: a year of firsts in the midst of a pandemic
oncology approvals, pandemic, FDA, biosimilar, oncology, COVID-19
Despite the global COVID-19 pandemic, 2020 was an active year for the OCE. In 2021, the OCE is engaging in Project 2025, an effort to envision the next 5 years in oncology drug development and leverage our resources and talents to improve collaboration with stakeholders to move the field forward as …
Jan 29th • 4 mins read
Chad Williamson, MBA, MS Leanne Berger, BS, Thomas P. Sullivan, BS SHOW
Addressing oncologists' gaps in the use of biosimilar products
biosimilar products, FDA, biosimilars, COA
The study highlights significant gaps in knowledge, competence, and confidence among oncologists regarding biosimilars. Educational interventions notably improved clinicians' understanding of the biosimilar approval process and familiarity with approved products. Post-education familiarity with the …
Jun 19th • 5 mins read
Steven Sorscher
Clinical Trials in Oncology and Defining Benefit
The article emphasizes the importance of defining efficacy and futility in oncology clinical trials from the patient's perspective, highlighting that what may be effective for one patient could be futile for another. It advocates for precision oncology, which integrates improved efficacy markers wit…
Jan 22nd • 1 min read