iated with a higher incidence in grade 3 lymphopenia or higher (44.9% inthe 5.25 mg per kg group vs. 25.6% in the 3.5 mg per kg group). Ninety-two percent of patientstreated with MAVENCLAD 3.5 mg per kg and 87% of patients receiving placebo completed thefull 96 weeks of the study.
The primary outcome of Study 1 was the annualized relapse rate (ARR). Additional outcomemeasures included the proportion of patients with confirmed disability progression, the time tofirst qualifying relapse, the mean number of MRI T1 Gadolinium-enhancing (Gd+) lesions, andnew or enlarging MRI T2 hyperintense lesions. Disability progression was measured in terms ofa 3-month sustained change in EDSS score of at least one point, if baseline EDSS score wasbetween 0.5 and 4.5 inclusively, or at least 1.5 points if the baseline EDSS score was 0, or atleast 0.5 point if the baseline EDSS score was at least 5, over a period of at least 3 months.
MAVENCLAD 3.5 mg per kg significantly lowered the annualized relapse rate. The results fromStudy 1 are presented in Table 4.
Table 4 Clinical Outcomes in Study 1 (96 Weeks) - Primary and Secondary
Endpoints
Endpoints
MAVENCLAD
Cumulative Dose 3.5 mg per kg
(n = 433)
Placebo
(n = 437)
Clinical Endpoints
Annualized relapse rate (ARR) 0.14* 0.33
Relative reduction in ARR 58%
Proportion of patients without relapse 81%** 63%
Time to 3-month confirmed EDSS
progression, HR 0.67**
Proportion of patients with 3-month
EDSS progression 13% 19%
MRI Endpoints
Median Number of Active T1 Gd+
Lesions 0* 0.33
Median Number of Active T2 Lesions 0* 0.67
* p < 0.001 compared to placebo
** nominal p < 0.05 compared to placebo
HR: Hazard Ratio
15 REFERENCES
1 "OSHA Hazardous Drugs". OSHA.
http://www.osha.gov/SLTC/hazardousdrugs/index.html.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
MAVENCLAD tablets, 10 mg, are uncoated, white, round, biconvex, and engraved with a "C"on one side and “10” on the other side. Each tablet is packaged in a child-resistant day packcontaining one or two tablets in a blister card.
Dispense one box for each treatment cycle with a Medication Guide [see Dosage andAdministration (2.2)].
Presentations
NDC 44087-400-04 Box of 4 tablets: Four day packs each containing one tablet.
NDC 44087-400-05 Box of 5 tablets: Five day packs each containing one tablet.
NDC 44087-400-06 Box of 6 tablets: One day pack containing two tablets. Four day packs
each containing one tablet.
NDC 44087-400-07 Box of 7 tablets: Two day packs each containing two tablets. Three day
packs each containing one tablet.
NDC 44087-400-08 Box of 8 tablets: Three day packs each containing two tablets. Two day
packs each containing one tablet.
NDC 44087-400-09 Box of 9 tablets: Four day packs each containing two tablets. One day
pack containing one tablet.
NDC 44087-400-10 Box of 10 tablets: Five day packs each containing two tablets.
16.2 Storage and Handling
Store at controlled room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted to
15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in original
package in order to protect from moisture.
MAVENCLAD is a cytotoxic drug. Follow applicable special handling and disposal procedures
[see References (15)].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Malignancies
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