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Cosela FDA Approval History

Last updated by Judith Stewart, BPharm on March 4, 2021.

FDA Approved: Yes (First approved February 12, 2021)
Brand name: Cosela
Generic name: trilaciclib
Dosage form: for Injection
Company: G1 Therapeutics, Inc.
Treatment for: Small Cell Lung Cancer Myelopreservation Therapy

Cosela (trilaciclib) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor myelopreservation therapy for use in patients with small cell lung cancer (SCLC) who are receiving chemotherapy.

  • Cosela works to help protect bone marrow (myeloprotection) when administered prior to treatment with a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).
  • Cosela is administered intravenously as a 30-minute infusion within four hours prior to the start of chemotherapy.
  • Common adverse reactions include fatigue, hypocalcemia, hypokalemia, hypophosphatemia, increased aspartate aminotransferase, headache, and pneumonia.

Development Timeline for Cosela

Feb 12, 2021Approval  FDA Approves Cosela (trilaciclib) to Decrease the Incidence of Chemotherapy-Induced Myelosuppression
Aug 17, 2020G1 Therapeutics Announces Acceptance and Priority Review of NDA for Trilaciclib for Patients with Small Cell Lung Cancer
Jun  1, 2019G1 Therapeutics Presents Additional Phase 2 Data on Trilaciclib in Small Cell Lung Cancer at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting
Oct 21, 2018G1 Therapeutics Presents Additional Data from Randomized Phase 2 Trial of Trilaciclib in Combination with Etoposide/Carboplatin for Treatment of First-Line Small Cell Lung Cancer

Further information

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