KTE-X19 Pivotal MCL Data Published in NEJM as FDA Weighs Approval
April 4th 2020Findings from the pivotal phase II ZUMA-2 trial of KTE-X19 as a treatment for adult patients with relapsed/refractory mantle cell lymphoma were published in the New England Journal of Medicine, as the FDA considers a biologics license application for the CAR T-cell therapy for an approval in this setting.
Almonertinib Approved in China for EGFR T79M+ NSCLC
March 19th 2020The Chinese National Medical Products Administration has approved almonertinib (Ameile; HS-10296) for the treatment of patients with EGFR T790M mutation–positive non–small cell lung cancer who have progressed on or after other EGFR TKI therapy.
Anti-BCMA Approaches Ascending in Multiple Myeloma
November 7th 2019Anti-BCMA directed treatments, including CAR T-cell therapy, bispecific antibodies, and antibody-drug conjugates, have the potential to revolutionize the multiple myeloma treatment paradigm. At the 37 Annual CFS®, Sham Mailankody, MBBS, discussed the emerging BCMA-directed therapies that have shown the greatest potential.
FDA Grants Brentuximab Vedotin Breakthrough Designation for Frontline CD30+ PTCL
November 16th 2018The FDA has granted brentuximab vedotin a breakthrough therapy designation for use in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma.
Tisagenlecleucel Nears European Approval for DLBCL, ALL
June 29th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of tisagenlecleucel for the treatment of either adult patients with diffuse large B-cell lymphoma that is relapsed or refractory after 2 or more lines of systemic therapy, or patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory, in relapse posttransplant, or in second or later relapse.
FDA Approves Pembrolizumab for Relapsed/Refractory PMBCL
June 13th 2018The FDA has granted an accelerated approval to pembrolizumab for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or those who have relapsed after 2 or more prior lines of therapy.
FDA Grants Crizotinib Breakthrough Designation for MET+ NSCLC and ALK+ ALCL
May 30th 2018The FDA has granted crizotinib a breakthrough therapy designation for the treatment of patients with metastatic non–small cell lung cancer with MET exon 14 alterations, and for use in patients with relapsed/refractory ALK+ anaplastic large cell lymphoma.
FDA Approves Tisagenlecleucel for Large B-Cell Lymphoma
May 2nd 2018The FDA has approved tisagenlecleucel (Kymriah) for use in adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma—after 2 or more lines of systemic therapy.
European Panel Recommends Against Adjuvant Sunitinib for High-Risk RCC
February 27th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended against approving sunitinib for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are high risk for recurrence.
FDA Grants Pembrolizumab/Lenvatinib Breakthrough Designation for RCC
January 9th 2018The FDA has granted the combination of the PD-1 inhibitor pembrolizumab and the VEGF/FGF inhibitor lenvatinib a breakthrough therapy designation for the treatment of patients with advanced and/or metastatic renal cell carcinoma.
FDA Panel Splits on Adjuvant Sunitinib in High-Risk RCC
September 20th 2017The FDA’s Oncologic Drugs Advisory Committee voted 6-6 on the potential approval of sunitinib for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are at high risk of recurrence.