Flatiron Health real-world data supports FDA approval of a new dosage regimen for ERBITUX® (cetuximab) | Companies

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NEW YORK – (BUSINESS WIRE) – Aug. July 2021–

Real-World (RWD) data from Flatiron Health supports the recent approval by the US Food and Drug Administration (FDA) of a new dosage regimen for ERBITUX ® (cetuximab by Eli Lilly and Company), which has a direct positive effect on the life of the population Patients may have metastatic colorectal cancer (CRC) or squamous cell carcinoma of the head and neck (SCCHN).

The FDA cleared a supplementary biologic (sBLA) filing for ERBITUX, which provides a new bi-weekly dosing regimen for indicated use of the drug in patients with wild-type K-Ras, EGFR-expressing metastatic CRC, or SCCHN when used as a single agent or in combination with chemotherapy.

This alternative dosing schedule to the previously approved weekly dosing schedule allows ERBITUX infusions to be scheduled along with other bi-weekly treatments, significantly reducing the frequency of patient visits to an infusion center.

“Time is a precious commodity for patients with advanced cancer – every moment that you don’t spend traveling to and from the clinic or in the clinic is a moment in which you live your life,” said Michael Vasconcelles, MD, Chief Medical Officer at Flatiron Health. “We are proud that Flatiron RWD is applying the knowledge we gain from the practical experience of patients directly to improving their care.”

“This dose change approval allows clinicians to offer our patients the same effective treatments with less frequent clinic visits,” said Lee Schwartzberg, MD, chief medical officer at OneOncology, a longtime oncology partner of the Flatiron Community. “It is encouraging to see the innovative use of real world data and regulatory pathways that made this label change a reality.”

The approval decision marked fundamental evidence for the successful use of RWD to fill the evidence gaps in the context of reauthorisation for regulatory decisions. Efficacy results from overall survival studies with Flatiron RWD in patients with metastatic CRC who received either the weekly or bi-weekly ERBITUX dosing regimen supported the results of the population pharmacokinetic model analyzes in the sBLA. The application was also supported by pooled analyzes of overall response rates, progression-free survival, and overall survival (OS) from the published literature in patients with CRC and SCCHN.

“We are proud that our longstanding partnership with Flatiron Health is helping drive real-world evidence adoption to support regulatory decisions,” said Christian Nguyen, Pharm.D., Vice president of global patient outcomes and real world evidence, Lilly Oncology. “The ability to close key evidence gaps through rigorous analysis of high-quality real-world data will help all of us deliver potential new treatment options for approved drugs to patients more quickly.”

About Flatiron Health

Flatiron Health is a healthcare technology company dedicated to helping cancer centers thrive and better care for patients today and tomorrow. Through clinical and data science, we translate patient experiences into real evidence to improve treatment, educate policy, and advance research. Cancer is smart. Together we can be smarter. Flatiron.com @FlatironHealth

ERBITUX ® is a trademark owned or licensed to Eli Lilly and Company, its subsidiaries or affiliates.

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Barbara Rosen, Director, Corporate Communications, barbara.rosen @ flatiron.com

KEYWORD: UNITED STATES NORTH AMERICA NEW YORK

INDUSTRY KEYWORD: BIOTECHNOLOGY FDA PHARMACEUTICAL HEALTH

SOURCE: Flatiron Health

Copyright Business Wire 2021.

PUB: 07/20/2021 10:22 a.m. / DISC: 07/20/2021 10:22 a.m.

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