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The FDA has approved the approval of CT-P10 lymphoma (Truxima; rituximab-abbs) biosimilar rituximab (Rituxan) for the treatment of adult patients with CD20-positive non-Hodgkin's B-cell lymphoma, in combined with chemotherapy, making it the first biosimilar approved by the FDA for the treatment of NHL patients.
Developed by Celltrion and Teva Pharmaceutical Industries, CT-P10 is approved for indications equivalent to standard rituximab. These indications include: relapsed / refractory, low-grade or follicular lymphoma, B-cell NHL positive for CD20 monotherapy; Previously untreated follicular lymphoma, CD20 positive B-cell NHL in combination with first-line chemotherapy and, in patients with a complete or partial response to a rituximab-based product in combination with chemotherapy, treatment with single agent interview; and LNL of low-grade, non-progressive or stable CD20-positive B-cells as monotherapy after first-line chemotherapy with cyclophosphamide, vincristine and prednisone (CVP).
"The Truxima approval is our third biosimilar endorsement last month," said Scott Gottlieb, MD, commissioner of the FDA, in a press release. "The growing pipeline of biosimilars is encouraging, we are seeing more and more biosimilar drugs gaining market share as the industry evolves, and we will continue to ensure that biosimilars are effectively badessed through process ensuring that these new drugs meet the rigorous criteria of the FDA. " approval standards. "
The biosimilar was approved on the basis of data including complete structural and functional characterization, animal test data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data demonstrating the similarity of CT. -P10 with reference rituximab.
The most common side effects seen with the biosimilar are infusion reactions, fever, lymphopenia, chills, infection, and asthenia. Patients should be monitored for tumor lysis syndrome, cardiac adverse effects, renal toxicity, as well as for obstructions and intestinal perforations.
In addition, patients should not receive vaccines during treatment and the biosimilar should not be administered to pregnant or badfeeding patients, the FDA said in the press release.
Similar to the standard rituximab, the CT-P10 label contains a warning regarding increased risk of life-threatening infusion reactions, serious skin and mouth reactions, hepatitis B virus reactivation and multifocal leukoencephalopathy. progressive, a serious and rare brain infection that can lead to severe disability or death.
"As part of the FDA biosimilars action plan, we are proposing new policies to make the development of biosimilars more efficient and to provide more opportunities for biosimilar manufacturers to market these products successfully and competitively." Our goal is to promote a competition capable of developing patients' access to important medications, "Gottlieb said in the statement.
Reference:
The FDA approves the first biosimilar for the treatment of non-Hodgkin's lymphoma in adults. FDA. Posted on November 28, 2018. https://bit.ly/2KD2hOu. Accessed November 28, 2018.
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