FDA News

FDA panel unanimously backs Rituxan biosimilar for lymphoma

The FDA’s Oncologic Drugs Advisory Committee voted 16-0 to support the licensure of CT-P10 as a rituximab biosimilar for three non-Hodgkin lymphoma indications sought by the agent’s manufacturer.

The indications include the treatment of adults 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 first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab (Rituxan; Genentech, Biogen) product in combination with chemotherapy, as single-agent maintenance therapy; and
  • nonprogressing (including stable disease), low-grade, CD20-positive, B-cell cell non-Hodgkin lymphoma, as a single agent after first-line cyclophosphamide, vincristine and prednisone chemotherapy.

CT-P10 (Celltrion) is a proposed biosimilar to Rituxan and is approved for use in the European Union.

Oncologic Drugs Advisory Committee (ODAC) members heard data on analytical similarity, nonclinical pharmacology and toxicology, and immunogenicity, as well as results from three clinical trials assessing CT-P10, including one among patients with rheumatoid arthritis and two among patients with follicular lymphoma.

In one study of 140 patients, researchers noted a higher incidence of neutropenia among patients assigned CT-P10 (2.9% vs. 1.4%). However, a second trial of 258 patients did not replicate this finding.

“The analytical data, using an array of analytical methods, demonstrate that CT-P10 is highly similar to U.S.-Rituxan, notwithstanding minor differences in clinically inactive components,” a summary of FDA findings presented at the meeting stated. “Pharmacokinetic, immunogenicity and clinical efficacy data support a demonstration that there are no clinically meaningful differences.”

Brian I. Rini, MD, FACP, chairman of the ODAC committee, professor of medicine at Learner College of Medicine, leader of the GU Program at the Cleveland Clinic Taussig Cancer Institute, and a HemOnc Today Editorial Board Member, said the consistent preclinical analytics served as a basis for his affirmative vote.

“I think the clinical data support efficacy in terms of, at least, response rate,” he said. “There were some concerns about safety, and I think that’s probably just what you get when you have a lower number of patients treated in this type of development program. You get some imbalances in baseline characteristics that, to me, seemed to explain some of the differences observed.”

Other committee members voiced similar views.

“In the totality of the data, I didn’t see any signals of safety, and I hope that in the future this can be applied to other applications where rituximab is used,” said Massimo Cristofanilli, MD, FACP, associate director of translational research and precision medicine at the Robert H. Lurie Comprehensive Cancer Center. – by Cassie Homer

The FDA often follows the guidance of ODAC when making its final decision on an agent’s approval, but the agency is not obligated to do so.

Disclosure: HemOnc Today could not confirm the committee members’ relevant financial disclosures at the time of publication.

The FDA’s Oncologic Drugs Advisory Committee voted 16-0 to support the licensure of CT-P10 as a rituximab biosimilar for three non-Hodgkin lymphoma indications sought by the agent’s manufacturer.

The indications include the treatment of adults 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 first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab (Rituxan; Genentech, Biogen) product in combination with chemotherapy, as single-agent maintenance therapy; and
  • nonprogressing (including stable disease), low-grade, CD20-positive, B-cell cell non-Hodgkin lymphoma, as a single agent after first-line cyclophosphamide, vincristine and prednisone chemotherapy.

CT-P10 (Celltrion) is a proposed biosimilar to Rituxan and is approved for use in the European Union.

Oncologic Drugs Advisory Committee (ODAC) members heard data on analytical similarity, nonclinical pharmacology and toxicology, and immunogenicity, as well as results from three clinical trials assessing CT-P10, including one among patients with rheumatoid arthritis and two among patients with follicular lymphoma.

In one study of 140 patients, researchers noted a higher incidence of neutropenia among patients assigned CT-P10 (2.9% vs. 1.4%). However, a second trial of 258 patients did not replicate this finding.

“The analytical data, using an array of analytical methods, demonstrate that CT-P10 is highly similar to U.S.-Rituxan, notwithstanding minor differences in clinically inactive components,” a summary of FDA findings presented at the meeting stated. “Pharmacokinetic, immunogenicity and clinical efficacy data support a demonstration that there are no clinically meaningful differences.”

Brian I. Rini, MD, FACP, chairman of the ODAC committee, professor of medicine at Learner College of Medicine, leader of the GU Program at the Cleveland Clinic Taussig Cancer Institute, and a HemOnc Today Editorial Board Member, said the consistent preclinical analytics served as a basis for his affirmative vote.

“I think the clinical data support efficacy in terms of, at least, response rate,” he said. “There were some concerns about safety, and I think that’s probably just what you get when you have a lower number of patients treated in this type of development program. You get some imbalances in baseline characteristics that, to me, seemed to explain some of the differences observed.”

Other committee members voiced similar views.

“In the totality of the data, I didn’t see any signals of safety, and I hope that in the future this can be applied to other applications where rituximab is used,” said Massimo Cristofanilli, MD, FACP, associate director of translational research and precision medicine at the Robert H. Lurie Comprehensive Cancer Center. – by Cassie Homer

The FDA often follows the guidance of ODAC when making its final decision on an agent’s approval, but the agency is not obligated to do so.

Disclosure: HemOnc Today could not confirm the committee members’ relevant financial disclosures at the time of publication.

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