OVERVIEW

PRODUCT INFORMATION

REPRESENTATIVE TRADE NAMES

Selinexor – Xpovio®

DRUG CLASS

Antineoplastic Agents

COMPLETE LABELING

Product labeling at DailyMed, National Library of Medicine, NIH

CHEMICAL FORMULA AND STRUCTURE

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DRUG	CAS REGISTRY NUMBER	MOLECULAR FORMULA	STRUCTURE
Selinexor	1393477-72-9	C17-H11-F6-N7O

ANNOTATED BIBLIOGRAPHY

SELECTED BIBLIOGRAPHY

References updated: 29 April 2023

• Zimmerman HJ. Hepatotoxic effects of oncotherapeutic and immunosuppressive agents. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 673-708.

  (Expert review of hepatotoxicity of cancer chemotherapeutic agents published in 1999 before the availability of selinexor).
• DeLeve LD. Cancer chemotherapy. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam, Elsevier, 2013, p. 541-68.

  (Review of hepatotoxicity of cancer chemotherapeutic agents; selinexor is not discussed).
• Isaacs C, Wellstein A, Riegel AT. Hormones and related agents in the therapy of cancer. Natural products in cancer chemotherapy: hormones and related agents. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1237-48.

  (Textbook of pharmacology and therapeutics).
• FDA. https://www​.accessdata​.fda.gov/drugsatfda_docs​/nda/2019/212306Orig1s000MultidisciplineR.pdf.

  (FDA Drug Approvals website that has product labels [package inserts], letters of approval and full FDA scientific review of the new drug application for safety and efficacy; mentions that ALT elevations arose in 8.4% of treated patients and were above 5 times the ULN in 2.5% but no patient developed jaundice or symptoms of acute liver injury).
• Grosicki S, Simonova M, Spicka I, Pour L, Kriachok I, Gavriatopoulou M, Pylypenko H, et al. Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial. Lancet. 2020;396(10262):1563–1573. [PubMed: 33189178]

  (Among 402 adults with relapsed or refractory multiple myeloma treated with bortezomib and dexamethasone with or without selinexor [100 mg once weekly], progression-free survival was longer with addition of Selinexor [13.2 vs 9.5 months]; no mention of ALT elevations or hepatotoxicity).
• Azmi AS, Uddin MH, Mohammad RM. The nuclear export protein XPO1 – from biology to targeted therapy. Nat Rev Clin Oncol. 2021;18:152–169. [PubMed: 33173198]

  (Description of the nuclear export proteins, their role in cell integrity, and the development of specific small molecular inhibitors and their possible therapeutic activities).
• Kalakonda N, Maerevoet M, Cavallo F, Follows G, Goy A, Vermaat JSP, Casasnovas O, et al. Selinexor in patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL): a single-arm, multinational, multicentre, open-label, phase 2 trial. Lancet Haematol. 2020;7:e511–e522. [PubMed: 32589977]

  (Among 175 adults with relapsed or refractory diffuse large cell B cell lymphoma treated with selinexor [60 mg on days 1 and 3 weekly], the overall response rate was 28% and adverse events included thrombocytopenia, anemia, neutropenia, fatigue, and nausea, but there were no drug related deaths and no liver related severe adverse events; no mention of ALT elevations).
• Chari A, Vogl DT, Gavriatopoulou M, Nooka AK, Yee AJ, Huff CA, Moreau P, et al. Oral selinexor-dexamethasone for triple-class refractory multiple myeloma. N Engl J Med. 2019;381:727–738. [PubMed: 31433920]

  (Among 122 adults with relapsed or refractory multiple myeloma treated with selinexor [80 mg twice weekly], 26% had at least a partial response, the median progression-free survival was 3.7 months and overall survival 8.6 months, while side effects were frequent including thrombocytopenia [73%], anemia [62%], neutropenia [40%], fatigue [73%], nausea [72%], decreased appetite [56%], weight loss [50%], diarrhea [46%], and hyponatremia [37%]; no mention of ALT elevations or hepatotoxicity).
• Syed YY. Selinexor: first global approval. Drugs. 2019;79:1485–1494. [PubMed: 31429063]

  (Review of the mechanism of action, history of development, pharmacokinetics, clinical efficacy, and safety of Selinexor, the first-in-class, oral, small molecule inhibitor of nuclear Exportin-1; no mention of hepatotoxicity or serum ALT elevations during therapy).