On June 28, 2019, the FDA approved another biosimilar for bevacizumab (Avastin), called Zirabev (bevacizumab-bvxr) for five different cancer types including:
- Metastatic colorectal cancer
- Unresectable, locally advanced, recurrent, or metastatic non squamous non-small cell lung cancer (NSCLC)
- Recurrent glioblastoma
- Metastatic renal cell carcinoma, and
- Persistent, recurrent, or metastatic cervical cancer.
WHAT DOES THIS UPDATE MEAN FOR PATIENTS?
Having additional treatment options is good news for metastatic colorectal cancer patients! Biosimilar treatments are being developed in an attempt to expand patient access to therapies and drive down the costs of biologic treatments.
Based on data presented at ASCO 2019, research showed that Zirabev was no different than bevacizumab in patients with Non-Small Cell Lung Cancer (NSCLC). Over 400 patients were studied in the clinical trial (REFLECTIONS B7391003), contributing to the data that led to FDA approval.
Below is a blog from September 2017 covering the FDA approval of the first biologic cancer drug, Mvasti.
Biosimilars are the new kid on the block
In 2017, the biologic Mvasi (bevacizumab-awwb; ABP-215), was approved by the FDA to treat colorectal and other cancers. Biosimilars are “similar” to another type of drug (called biologics) already approved by the FDA.
Learn more about what biologics are and what they are not here!
Biosimilars and biologics are equal in terms of effectiveness (meaning, there are not clinically significant differences), but they are slightly different because biologic drugs are derived from living organisms versus chemicals.
Biosimilars have been used in Europe for many years; however, on September 14, 2017, the Food and Drug Administration approved the first biosimilar EVER in the United States to treat cancer. Leading up to the approval, Fight CRC ensured the patient voice remained at the forefront of the conversation by providing public comment to the FDA’s Meeting of the Oncologic Drugs Advisory Committee.
This is important.
Why? Because it offers more options for patients with the potential to drive down costs and increase patient access to therapies! As biosimilars become available, we will keep an eye on price and access to patient assistance programs.
More about Mvasi
In July 2017 the FDA’s Oncologic Drugs Advisory Committee voted 17-0, recommending the approval of the biosimilar, Mvasi (bevacizumab-awwb; ABP-215). Mvasi is a biosimilar of the biologic Avastin (bevacizumab) and has been approved to treat a variety of adult cancer types including lung, brain, kidney, cervical and colorectal cancers.
Fight CRC continues to ensure the patient voice remains at the forefront of the conversation.
While there are a handful of indications for the use of Mvasi, for colorectal cancer patients, Mvasi has been approved for the following:
- 1st or 2nd line treatment for metastatic CRC (mCRC), in combination with 5-fluorouracil (5-FU) based chemo
- 2nd line treatment for mCRC, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemo for patients whose cancer progressed on 1st line bevacizumab
How do we know it works?
A number of studies were carried out comparing Avastin (bevacizumab) and ABP-215. One was a 3-arm, a single-dose study comparing ABP-215 with bevacizumab (both US and EU approved), and the other was a comparative clinical study. In the comparative clinical study, overall response rates to the new treatment were more or less the same as they are for bevacizumab:
- Response Rates: 39% for ABP-215, and 41.7% for EU-bevacizumab
- Both groups had 2 patients with complete responses
- The duration of response was 5.8 months for ABP-215 and 5.6 months for bevacizumab).
In addition, the side effects were also quite similar, with no meaningful differences. Source: ODAC Unanimously Supports Bevacizumab Biosimilar ABP-215
Stay tuned as Fight CRC continues to follow the development of biosimilar drugs for colorectal cancer. Check out Your Guide in the Fight for tips and resources regarding the cost of cancer and our mini-magazine on biosimilars. This topic continues to be an emerging area of interest and we will make sure the patient voice remains at the forefront of the conversation.
Fight Colorectal Cancer has received funding from Amgen (producers of Mvasi) and Genentech (producers of Avastin). Funding has come in the form of unrestricted educational grants. We maintain ultimate authority over website content and the content written in this article. Fight Colorectal Cancer never recommends or endorses any specific physicians, products or treatments for any condition.