Janssen Research & Development, LLC (Janssen) has initiated the rolling submission of its Biologic License Application (BLA) for daratumumab to the US Food and Drug Administration (FDA) for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and an IMiD.

Daratumumab – an investigational human anti-CD38 monoclonal antibody – received Breakthrough Therapy Designation by the FDA for this set of patients in May 2013.

A rolling submission allows the company to submit portions of the regulatory application to the FDA as they are completed.¹
           
In August 2012, Janssen Biotech, Inc. and Genmab A/S entered into an agreement which granted Janssen a worldwide exclusive license to develop, manufacture and commercialise daratumumab.

With the exception of one study sponsored globally by the French multiple myeloma cooperative group, Intergroupe Francophone du Myelome (IFM), Janssen is the global sponsor of all current and future clinical studies for daratumumab.

Multiple myeloma is an incurable blood cancer.²

Approximately 26,850 new patients will be diagnosed with multiple myeloma and approximately 11,240 people will die from the disease in the US in 2015.³

Patients who relapse after treatment with standard therapies, including PIs or IMiDs, have poor prognoses and few treatment options.⁴

The regulatory submission for daratumumab will be primarily supported by data from the Phase 2 MMY2002 (SIRIUS) monotherapy study announced in May 2015 at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO), along with additional data from four other studies, including the Phase 1/2 GEN501 monotherapy study.

If approved, daratumumab would be commercialised in the US by Janssen Biotech, Inc.

References

1. US Food and Drug Administration. “Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics.” Available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf. Accessed June 2015.

2. American Cancer Society. “Multiple Myeloma Overview.” http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma. Accessed June 2015.

3. American Cancer Society. “What are the key statistics about multiple myeloma?” http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-key-statistics. Accessed June 2015.

4. Kumar, SK et al. Leukemia. 2012 Jan;26(1):149-57.
[v] American Cancer Society. “Multiple Myeloma Overview.” http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma. Accessed June 2015.
[vi] National Cancer Institute. “A Snapshot of Myeloma.” Available at www.cancer.gov/research/progress/snapshots/myeloma. Accessed June 2015.

7 GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide. Available at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx. Accessed June 2015.

8 American Cancer Society. “How is Multiple Myeloma Diagnosed?” http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis. Accessed June 2015.
[ix] Jansen JH, et al. Blood. 2012; 120.2974

Source: Janssen