FDA Approves Darzalex (daratumumab) Split-Dosing Regimen

Horsham, PA, February 12, 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved a split-dosing regimen for Darzalex® (daratumumab), providing healthcare professionals and patients with multiple myeloma an option to split the first infusion over two consecutive days.[1] The U.S. FDA approval is based on data from the Phase 1b EQUULEUS (MMY1001) clinical study, which demonstrated Darzalex pharmacokinetic (PK) concentrations were comparable at the end of weekly dosing, regardless of whether the first dose was administered as a split infusion or as a single infusion.1

“The first infusion of Darzalex is an important first step in a patient’s course of therapy, and this approval provides added flexibility for how patients may receive initial treatment,” said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Janssen Research & Development, LLC. “We are committed to exploring options that may improve the overall treatment experience for patients.”

The U.S. FDA approval of a split-dosing regimen for Darzalex is based on data from the global, multi-arm, Phase 1b EQUULEUS (MMY1001) study in multiple myeloma, which evaluated Darzalex in combination with various treatment regimens.1 Splitting the first dose of Darzalex over two consecutive days effectively reduced the duration of the first infusion and resulted in a similar rate and pattern of infusion reactions.1 Data from the study demonstrated that Darzalex concentrations were comparable at the end of weekly dosing regardless of whether the first 16 mg/kg dose was administered as a split infusion or single first infusion.1

The safety profile of DARZALEX was comparable when administered initially as a split or single dose, and no new safety events were observed with a split first dose.1

This approval follows approvals in Canada and the European Union in December 2018 for the Darzalex initial infusion split-dosing regimen.

About Darzalex (daratumumab) Injection for Intravenous Infusion

Darzalex is the first and only CD38-directed antibody to receive regulatory approval to treat multiple myeloma.[2] In the U.S., Darzalex (daratumumab) first received FDA approval in November 2015 as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent.[3] Darzalex received additional approvals in November 2016 in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.[4] In June 2017, Darzalex received approval in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a PI.[5] Most recently, in May 2018, Darzalex received approval in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant, making it the first monoclonal antibody approved for newly diagnosed patients with this disease.[6]

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered into a global license and development agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize Darzalex.[7] For the full U.S. Prescribing Information, please visit www.DARZALEX.com.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.[8],[9] Refractory cancer occurs when a patient's disease is resistant to treatment or in the case of multiple myeloma, when patients progress within 60 days of their last therapy.[10],[11] Relapsed cancer means the disease has returned after a period of initial, partial or complete remission.[12] In 2019, it is estimated that 32,110 people will be diagnosed, and 12,960 will die from the disease, in the United States.[13] While some patients with multiple myeloma have no symptoms, most patients are diagnosed due to symptoms, which can include bone fracture or pain, low red blood counts, fatigue, high calcium levels, kidney problems or infections.[14]

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at @JanssenGlobal and @JanssenUS. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

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This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the benefits of Darzalex® (daratumumab) for the treatment of patients with multiple myeloma. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., and any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; [product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, 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, 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. Neither the Janssen Pharmaceutical Companies of Johnson & Johnson nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

Source: Janssen Pharmaceutical Companies of Johnson & Johnson

Posted: February 2019

Related Articles:

  • Janssen Announces Darzalex (daratumumab) U.S. FDA Approval for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible – May 7, 2018
  • Genmab Announces U.S. FDA Approval of Darzalex (daratumumab) in Combination with Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma – June 16, 2017
  • Darzalex (daratumumab) Approved by FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy – November 21, 2016
  • FDA Approves Darzalex (daratumumab) for Patients with Previously Treated Multiple Myeloma – November 16, 2015
  • U.S. FDA Grants Priority Review to Janssen for Daratumumab as a Treatment for Multiple Myeloma – September 4, 2015
  • Janssen Initiates Rolling Submission of BLA for Daratumumab for the Treatment of Multiple Myeloma – June 5, 2015
  • Genmab Announces Preliminary Results in Phase II Study of Daratumumab in Double Refractory Multiple Myeloma – February 3, 2015
  • Daratumumab Receives Breakthrough Therapy Designation in Double Refractory Multiple Myeloma from U.S. FDA – May 1, 2013
  • Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab – August 30, 2012

Darzalex (daratumumab) FDA Approval History

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