FDA Approves First Biosimilar for Treating Breast and Stomach Cancers

The FDA has approved the first biosimilar for the treatment of certain breast and stomach cancers, according to a press release from the administration.

Mylan GmbH’s trastuzumab-dkst (Ogivri) has been approved as a biosimilar to trastuzumab (Herceptin) for patients with breast or metastatic stomach cancer whose tumors overexpress the HER2 gene.

“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients,” said FDA Commissioner Scott Gottlieb, MD, in the statement. “We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”

According to the FDA, the approval of trastuzumab-dkst comes after a review of evidence that included:

• Extensive structural and functional characterization
• Animal study data
• Human pharmacokinetic and pharmacodynamics data
• Clinical immunogenicity data
• Other clinical safety and effectiveness data that demonstrates trastuzumab-dkst is biosimilar to trastuzumab.

Common side effects of trastuzumab-dkst for the treatment of HER2+ breast cancer include headache, diarrhea, nausea, congestive heart failure, insomnia, and infection. Common side effects of the biosimilar for the treatment of HER2+ metastatic stomach cancer include neutropenia, stomatitis, low levels of blood platelets, and anemia.

Like trastuzumab, the labeling for trastuzumab-dkst includes a boxed warning to advise healthcare professionals and patients about the increased risk for heart disease, infusion reactions, lung damage, and harm to a developing fetus.

Trastuzumab-dkst is the first biosimilar approved in the US for treating breast cancer or stomach cancer and the second biosimilar approved in the US for the treatment of cancer.