Issue: January, 2021
January 25, 2021
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FDA grants priority review, fast track status to several hematology/oncology products

Issue: January, 2021
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The FDA granted priority review designation and fast track status to several agents under investigation for the treatment of various solid tumors and hematologic malignancies.

The agency granted priority review to the following agents:

  • cemiplimab-rwlc (Libtayo; Regeneron, Sanofi) — a fully human monoclonal antibody that targets PD-1 — as first-line therapy for locally advanced or metastatic non-small cell lung cancer with 50% or greater PD-L1 expression;
  • infigratinib (BridgeBio Pharma/QED Therapeutics), an oral FGFR1-3 selective inhibitor, the treatment of cholangiocarcinoma;
  • loncastuximab tesirine (Lonca, ADC Therapeutics) — an antibody-drug conjugate composed of a humanized monoclonal antibody directed against CD19 and
  • conjugated through a linker to a pyrrolobenzodiazepine dimer cytotoxin — for treatment of relapsed or refractory diffuse large B-cell lymphoma;
  • nivolumab (Opdivo, Bristol Myers Squibb), an anti-PD-1 antibody, in combination with cabozantinib (Cabometyx, Exelixis), a multitargeted tyrosine kinase inhibitor, for treatment of advanced renal cell carcinoma;
  • pegcetacoplan (APL-2, Apellis Pharmaceuticals) — a targeted C3 therapy designed to regulate excessive activation of the complement cascade — for treatment of paroxysmal nocturnal hemoglobinuria;
  • pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy, plus fluoropyrimidine-based chemotherapy for the first-line treatment of locally advanced unresectable or metastatic esophageal and gastroesophageal junction cancer.

The following agents received fast track status:

  • devimistat (CPI-613, Rafael Pharmaceuticals), which targets enzymes in the mitochondria of cells involved in cancer cell energy metabolism, for the treatment of pancreatic cancer and, in a separate decision, for the treatment of acute myeloid leukemia;
  • irinotecan liposome injection, (Onivyde, Ipsen), a topoisomerase 1 inhibitor, for second-line monotherapy treatment of patients with small cell lung cancer whose disease progressed after a first-line platinum-based regimen;
  • RV001 (RhoVac) — a peptide-based immunotherapy designed to train the immune system to target cancer cells with metastatic potential — for the treatment of prostate cancer; and
  • SRF388 (Surface Oncology), a fully human anti-interleukin-27 antibody, for treatment of patients with hepatocellular carcinoma previously treated with standard therapies.