Click Here to
Subscribe
Breaking
News, Updates,
& More
Stay Up
to Date

Daratumumab Combination Approved for Multiple Myeloma

Web Exclusives - FDA Updates, In the News

On November 21, 2016, the U.S. Food and Drug Administration approved daratumumab (DARZALEX, Janssen Biotech, Inc.) 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.

Daratumumab was previously granted accelerated approval in November 2015 as 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.

The current approval was based on two randomized, open-label trials in which daratumumab was added to standard therapies. The POLLUX trial (also known as MMY3003), demonstrated substantial improvement in progression-free survival (PFS) when daratumumab was added to lenalidomide and dexamethasone compared with lenalidomide and dexamethasone alone. The estimated median PFS had not been reached in the daratumumab arm and was 18.4 months in the control arm (HR=0.37; 95% CI: 0.27, 0.52; p<0.0001), representing a 63% reduction in the risk of disease progression or death in patients treated with daratumumab.

Similar results were observed in the CASTOR trial (also known as MMY3004), which compared the combination of daratumumab, bortezomib, and dexamethasone with bortezomib and dexamethasone. The estimated median PFS was not reached in the daratumumab arm and was 7.2 months in the control arm (HR=0.39; 95% CI: 0.28, 0.53; p<0.0001), representing a 61% reduction in the risk of disease progression or death for patients treated with daratumumab.

The most frequently reported adverse reactions (greater than or equal to 20%) in MMY3003 were infusion reactions, diarrhea, nausea, fatigue, pyrexia, upper respiratory tract infection, muscle spasm, cough and dyspnea. The most frequently reported adverse reactions (greater than or equal to 20%) in MMY3004 were infusion reactions, diarrhea, peripheral edema, upper respiratory tract infection, peripheral sensory Neutropenia and thrombocytopenia have been added to the Warnings and Precautions of the DARZALEX label.

The recommended dose of daratumumab is 16 mg/kg intravenously (calculated on actual body weight).

FDA granted daratumumab breakthrough therapy and orphan drug designation, as well as priority review. The current approval was granted three months prior to the PDUFA date of February 17, 2017. A description of these expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions—Drugs and Biologics, available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf.

Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761036s004lbl.pdf

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

US Food and Drug Administration. Daratumumab (darzalex). Updated November 22, 2016.

Related Items
Opdivo plus Yervoy and Chemotherapy Approved as First-Line Therapy for Metastatic NSCLC, Regardless of PD-L1 Expression
Web Exclusives published on June 2, 2020 in FDA Updates, Lung Cancer
Tecentriq plus Avastin First Immunotherapy Regimen Approved for Metastatic Hepatocellular Carcinoma
Web Exclusives published on June 2, 2020 in FDA Updates, Hepatocellular Carcinoma
Lynparza First Targeted Therapy Approved for Metastatic Prostate Cancer with HRR Mutation
Web Exclusives published on May 26, 2020 in FDA Updates, Prostate Cancer
Tecentriq Approved as First-Line Therapy for Metastatic NSCLC with High PD-L1 Expression
Web Exclusives published on May 26, 2020 in FDA Updates, Lung Cancer
Opdivo-Yervoy First Immunotherapy Combo Approved for First-Line Therapy of Patients with Metastatic NSCLC
Web Exclusives published on May 18, 2020 in FDA Updates, Lung Cancer
Tabrecta First FDA-Approved Targeted Therapy for Metastatic NSCLC and MET Exon 14 Skipping
Web Exclusives published on May 11, 2020 in FDA Updates
Retevmo First Therapy Approved for 3 Types of Cancers with RET Mutations
Web Exclusives published on May 11, 2020 in FDA Updates
FDA Approves Darzalex Faspro as Subcutaneous Formulation for All Patients with Multiple Myeloma
Web Exclusives published on May 5, 2020 in FDA Updates
Zejula First PARP Inhibitor Approved as First-Line Maintenance Treatment for All Patients with Ovarian Cancer
Web Exclusives published on May 4, 2020 in FDA Updates
FDA Approves New 400 mg Every-6-Weeks Dosing Regimen of Keytruda for All Indications
Web Exclusives published on April 30, 2020 in FDA Updates
Last modified: April 27, 2020