New FDA Approved Indications for Oncology and Hematology in August

  • First Chemotherapy-Free Treatment for Waldenströms Macroglobulinemia. The combination of the Bruton tyrosine kinase inhibitor ibrutinib (Ibruvica®, Abbvie) and the anti-CD20 monoclonal antibody rituximab (Rituxan®, Genentech) was approved by the United States Food and Drug Administration (FDA) for treatment of patients with Waldenströms macroglobulinemia (WM). Approval of this regimen was based on results from the phase III iNNOVATE trial, in which 82% of patients with previously untreated and relapsed/refractory WM treated with ibrutinib plus rituximab were alive and progression free at 30 months, compared to only 28% of patients on rituximab monotherapy (HR 0.20; P<.0001).
  • New Therapy for Two Subtypes of Cutaneous T-Cell Lymphoma. Mogamulizumab-kpkc (Poteligeo®, Kyowa Kirin, Inc), a CC chemokine receptor type 4 (CCR4) targeting monoclonal antibody, was approved for treatment of adults with relapsed or refractory mycosis fungoides or Sézary syndrome who have received at least one prior systemic therapy. This decision was based on a 47% reduction in the risk of progression or death with mogamulizumab compared to vorinostat in the phase III MAVORIC trial. Mogamulizumab resulted in a 7.6-month median progression-free survival (PFS), compared to 3.1 months with vorinostat (HR 0.53).
  • Lenvatinib Approval Extended to Liver Cancer. The indication of the multikinase inhibitor lenvatinib (Lenvima®, Eisai) was extended to include first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). In the phase III REFLECT trial of 954 patients with previously untreated advanced HCC, lenvatinib demonstrated noninferiority to standard of care sorafenib in terms of overall survival (OS; 13.6 months vs 12.3 months; HR 0.92) and a statistically significant improvement in PFS, time to progression, and objective response.
  • First Immunotherapy for Small Cell Lung Cancer. The PD-1 inhibitor nivolumab (Opdivo®, Bristol-Myers Squibb) received accelerated approval for treatment of patients with metastatic small cell lung cancer (SCLC) who have progressed on platinum-based chemotherapy and at least one other line of treatment. This approval, based on results from the cohort of SCLC patients, included the multicenter phase I/II CheckMate-032 trial. In these patients (n = 109), treatment with nivolumab monotherapy was associated with a 12% objective response rate (ORR) with a median 17.9-month duration of response. A total of 62% of responding patients maintained their response at 12 months, and 39% were still in response at 18 months. Responses were seen regardless of PD-L1 expression.
  • Full Approval for First-Line Pembrolizumab and Chemotherapy for Nonsquamous NSCLC. Full approval was granted to pembrolizumab (Keytruda®, Merck & Co) in combination with platinum and pemetrexed chemotherapy for first-line treatment of patients with metastatic, nonsquamous non-small cell lung cancer (NSCLC) without EGFR or ALK This combination initially received accelerated approval on the basis of results from the phase II Keynote-021 cohort G trial. Full approval comes following results from the phase III Keynote-189 trial, in which pembrolizumab plus chemotherapy resulted in a significant improvement in both OS (not reached vs 11.3 months; HR 0.49, P<.001) and PFS (8.8 months vs 4.9 months; HR 0.52, P<.001) compared to chemotherapy alone in newly diagnosed patients with NSCLC.
  • PD-L1 Testing Requirement for Selecting Patients with Cisplatin Ineligible Advanced Bladder Cancer for Frontline Immunotherapy. The prescribing information for both pembrolizumab (Keytruda®, Merck & Co) and atezolizumab (Tecentriq®, Genentech) was updated to include a requirement for PD-L1 testing using an FDA-approved companion diagnostic in previously untreated cisplatin-ineligible patients with advanced urothelial carcinoma. The Dako PD-L1 IHC 22C3 PharmDx (Dako North America, Inc.) assay was approved for use with pembrolizumab. This test determines PD-L1 expression by using a combined positive score (CPS) assessing PD-L1 staining in tumor and immune cells. Pembrolizumab is indicated for cisplatin ineligible patients with CPS score ≥10. The Ventana PD-L1 (SP142) Assay® (Ventana Medical Systems, Inc) was approved as a companion diagnostic test to select cisplatin ineligible patients for treatment with atezolizumab. This test determines PD-L1 expression on immune cells. Atezolizumab is indicated if PD-L1 stained tumor infiltrating immune cells covering ≥5% of the tumor area.

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