Committee Supports FDA Approval of CT-P10 for Non-Hodgkin Lymphoma Treatment

The Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee voted 16-0 in support of the agency granting approval to CT-P10, a biosimilar of Rituxan (rituximab), which is a drug used to treat non-Hodgkin lymphoma.

The purpose of the Oncologic Drugs Advisory Committee is to review and evaluate data concerning the safety and effectiveness of marketed and investigational human drug products for their use in the treatment of cancer. In turn, the committee makes appropriate recommendations to the FDA’s commissioner.

A biosimilar is a biological product that, through trials and FDA evaluation, is proven to be very similar to the reference product — in this case Rituxan – with no clinically meaningful differences in safety, purity and potency. The first biosimilar in the oncology space in the U.S. was Mvasi, a biosimilar to Avastin (bevacizumab), which was approved in September of last year.

Therefore, in this instance, the committee was tasked with determining whether the data submitted in the agent’s biologics license application demonstrated the biosimilarity between CT-P10 and Rituxan in terms of efficacy, safety, pharmacology, analytical similarity, and immunogenicity.

During the ODAC meeting, key stakeholders in the field gathered to discuss the drug. The biosimilar was analyzed for the treatment of the following:

• adult patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin lymphoma as a single agent;
• previously untreated follicular, CD20-positive, B-cell non-Hodgkin lymphoma in combination with frontline chemotherapy and in patients who achieve a partial response to a Rituxan product in combination with chemotherapy, as a single-agent maintenance therapy; and
• non-progressing or stable disease, low-grade, CD20-postivie, B-cell non-Hodgkin lymphoma as a single agent after first-line cyclophosphamide, vincristine and prednisone (CVP) chemotherapy.

If CT-P10 is approved, the product could significantly decrease costs and mitigate some of the financial toxicity associated with treating the disease.

CT-P10 is already approved in more than 40 countries. According to Susannah Koontz, PharmD, BCOP, principal and consultant at Koontz Oncology, the price of biosimilars is about 30 percent of the price of their reference product in Europe, expanding access of cancer care.

“As an oncology pharmacist, I’m committed to patients having access to potentially life-saving medications.” Koontz said at the meeting, noting that the average expenditure of Rituxan in the United States is $3.5 billion. “The ever-increasing costs of cancer care are unsustainable.”

The approval in the United States is based off of two randomized, double-blind studies submitted with the biosimilar’s biologics license application. Both trials compared the biosimilar with the reference product, Rituxan, in terms of how well the drug works to treat the disease, as well as any major differences in side effects between the two arms.

“The overall incidence of adverse events were similar in the two treatment groups. There were no clinically meaningful differences in the occurrence of adverse events between the two groups,” said Rachel Ershler, M.D., clinical reviewer of hematology products at the FDA said.