November 25, 2020
1 min read

Investigational agents receive fast track designation for hematology/oncology indications

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The FDA granted fast track designation to several agents under investigation for the treatment of patients with certain solid tumors or hematologic malignancies.

These include:

  • aspacytarabine (BST-236, BioSight), a novel antimetabolite composed of cytarabine covalently bound to asparagine, for adults with acute myeloid leukemia who are aged 75 years or older or cannot receive induction chemotherapy;
  • BDTX-189 (Black Diamond Therapeutics) — an oral, irreversible small-molecule inhibitor that addresses oncogenic driver mutations of the ErbB kinases in EGFR and HER2 — for adults with solid tumors that harbor allosteric HER2 mutations, or EGFR or HER2 exon 20 insertion mutations, who progressed after prior therapy and have no satisfactory therapeutic treatment options;
  • DKN-01 (Leap Therapeutics) — a humanized monoclonal antibody that binds to and blocks activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling — for patients with gastric cancer or gastroesophageal junction adenocarcinoma whose tumors express high levels of DKK1 protein and whose disease progressed during or after fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2-targeted therapy;
  • paxalisib (GDC-0084, Kazia Therapeutics), a small-molecular inhibitor of the PI3K/AKT/mTOR pathway, for patients with newly diagnosed glioblastoma with unmethylated MGMT promotor status who completed initial radiation treatment with concomitant temozolomide;
  • the combination of ublituximab (TG-1101, TG Therapeutics), a glycoengineered monoclonal antibody that targets a specific epitope on the CD20 antigen found on mature B lymphocytes, and umbralisib (TGR-1202, TG Therapeutics), a dual inhibitor of PI3 kinase-delta and CK1-epsilon for adults with chronic lymphocytic leukemia; and
  • XMT-1536 (Mersana Therapeutics), an antibody-drug conjugate that targets the sodium-dependent phosphate transport protein NaPi2b, for the treatment of women with high-grade serous ovarian cancer, including those with platinum-resistant disease who have received up to three prior lines of systemic therapy or women who have received four prior lines of systemic therapy regardless of platinum status.

For more details on these actions and others, visit and search “FDA news.”