Janssen Submits Biologics License Application to U.S. FDA Seeking Approval of Teclistamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

By
-
0
30

, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.


[1] Moreau P et al. Updated Results From MajesTEC-1: Phase 1/2 Study of Teclistamab, a B-Cell Maturation Antigen x CD3 Bispecific Antibody, in Relapsed/Refractory Multiple Myeloma. 2021 American Society of Hematology Annual Meeting. December 2021.

[2] Kumar SK, et al. Leukemia. 2012 Jan; 26(1):149-57.

[3] American Cancer Society. “What Is Multiple Myeloma?.” Available at: http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma. Accessed December 2021.

[4] American Cancer Society: Cancer Facts & Statistics. American Cancer Society | Cancer Facts & Statistics. https://cancerstatisticscenter.cancer.org/#!/cancer-site/Myeloma. Accessed December 2021.

[5] American Cancer Society. “Key Statistics About Multiple Myeloma.” Available at: https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html. Accessed December 2021.

[6] Labrijn AF et al. Proc Natl Acad Sci USA. 2013;110:5145.

[7] Frerichs KA et al. Clin Cancer Res. 2020; doi: 10.1158/1078-0432.CCR-19-2299.

[8] Cancer Research Institute. “Adoptive Cell Therapy: TIL, TCR, CAR T, AND NK CELL THERAPIES.” Available at: https://www.cancerresearch.org/immunotherapy/treatment-types/adoptive-cell-therapy.

[9] Cho SF et al. Frontiers in Immunology. 2018; 9: 1821.

[10] Benonisson H et al. Molecular Cancer Therapeutics. 2019 (18) (2) 312-322.

[11] European Medicines Agency. PRIME Factsheet. Available at: https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines. Accessed December 2021.

[12] The U.S. Food and Drug Administration. “Expedited Programs for Serious Conditions.” Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf. Accessed December 2021.