The AJMC® Product Approvals and Launches page will cover the latest FDA product approvals, as well as product launches in the United States.
FDA Approves Cabozantinib for Advanced Pancreatic Neuroendocrine Tumors
March 26th 2025With strong progression-free survival benefits demonstrated in the CABINET trial and updates to National Comprehensive Cancer Network guidelines, this approval reinforces cabozantinib’s role in improving outcomes for patients facing these challenging cancers.
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How Revakinagene Taroretcel Can Benefit Patients With MacTel: Dr Charles Wykoff
March 26th 2025The approval of revakinagene taroretcel (Encelto; Neurotech) addresses a significant unmet need for patients with macular telangiectasia type 2 (MacTel), clinical investigator Charles C. Wykoff, MD, PhD, Retinal Consultants of Texas, said.
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Revakinagene Taroretcel Approval Addresses Unmet Need in MacTel
March 24th 2025Charles C. Wykoff, MD, PhD, Retinal Consultants of Texas, discusses data supporting the FDA approval of revakinagene taroretcel-lwey (Encelto; Neurotech Pharmaceuticals), the first and only therapy indicated for the treatment of macular telangiectasia type 2 (MacTel).
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Second CRL for Rivoceranib/Camrelizumab for Unresectable HCC
March 21st 2025Despite resubmitting after an initial complete response letter (CRL) due to manufacturing issues, the combination therapy received a second CRL as a frontline therapy for unresectable hepatocellular carcinoma (HCC).
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How Mirdametinib Improves QOL for People With NF1-Associated Plexiform Neurofibromas
March 18th 2025Christopher L. Moertel, MD, University of Minnesota, discusses the trial data that helped get mirdametinib approved and what providers can do to keep measuring quality of life (QOL) improvements.
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FDA Approves Brentuximab Vedotin, Lenalidomide, Rituximab Triplet for R/R LBCL
February 12th 2025Interim data from the ECHELON-3 trial previously showed that adding brentuximab vedotin to lenalidomide and rituximab improved overall survival among patients who have relapsed or refractory large B-cell lymphoma (R/R LBCL).
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Bimekizumab-bkzx Expands Treatment Options for Inflammatory Conditions
February 10th 2025Jeffrey Stark, MD, vice president and head of medical immunology at UCB, discusses tailored dosing of bimekizumab-bkzx (Bimzelx) for various inflammatory conditions, highlighting its 5 FDA approvals and the remaining challenges.
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Treosulfan Approval Offers Novel Option for Allo-HSCT Conditioning in AML/MDS
February 7th 2025Mikkael A. Sekeres, MD, Sylvester Comprehensive Cancer Center, discusses the potential benefits of treosulfan, a newly approved agent for allogeneic hematopoietic stem cell transplantation (allo-HSCT) conditioning in acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
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Treosulfan Shown Effective, Safe as Conditioning for Allo-HSCT in AML/MDS
February 6th 2025Mikkael A. Sekeres, MD, of Sylvester Comprehensive Cancer Center, University of Miami, discussed data supporting the FDA approval of treosulfan as part of conditioning for allogeneic hematopoeitic stem cell transplantation (allo-HSCT).
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