Rare Disease Report

FDA Approves Biosimilar for Cancer Treatment

SEPTEMBER 14, 2017
Mathew Shanley
The U.S. Food and Drug Administration (FDA) has approved a new version of Genentech’s Avastin (bevacizumab).

Amgen’s Mvasi (bevacizumab-awwb), a biosimilar to Avastin, is now permitted for use in adults to treat multiple types of cancer, including rare iterations of brain and kidney cancer.

A biosimilar is a biological product approved based on data proving that it is extremely like an already-approved biological product, with no clinically significant differences in terms of safety and efficacy, among other criteria. While 7 biosimilars have been previously approved by the FDA, Mvasi is the first to be approved for the treatment of cancer.

“Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies,” said FDA Commissioner Scott Gottlieb, M.D. in the press release.

Per the official FDA press release, approved indications include the treatment of the rare conditions glioblastoma and renal cell carcinoma. All indications include:
  • Cervical cancer that is persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
  • Glioblastoma with progressive disease following prior therapy, based on improvement in objective response rate. No data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab products.
  • Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
  • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrmidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
  • Non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease.
  • Metastatic renal cell carcinoma, in combination with interferon alfa.
“We’ll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA’s rigorous gold standard for safety and effectiveness,” continued Gottlieb.

Expected side effects of taking Mvasi include nose bleeds, headache, high blood pressure, dry skin, and others. Serious expected side effects can include holes or abnormal connection between organs, hypertension and issues with functionality in the brain. The drug comes with a Boxed Warning to alert health care professionals and patients about an increased risk of gastrointestinal perforations, in which case a patient are encouraged to stop taking the medication.

Health care professionals are suggested to review the prescribing information about approved uses.

For more from the FDA, including applications, designations and approvals, follow Rare Disease Report on Facebook and Twitter. To get breaking news sent directly to your inbox, sign up for the RDR e-newsletter.

Stay informed on the latest rare disease news and developments by signing up for our newsletter.
Copyright © RareDR 2013-2018 Rare Disease Communications. All Rights Reserved.