Investigational agents receive fast track designation for hematology/oncology indications
The FDA granted fast track designation to several agents under investigation for the treatment of patients with certain solid tumors or hematologic malignancies.
- 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.
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