0 mg ALIQOPA and 12 patients received 0.8 mg/kg equivalent ALIQOPA administered as a 1-hour intravenous infusion on Days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (three weeks on and one week off). Treatment continued until disease progression or unacceptable toxicity. Tumor response was assessed according to the International Working Group response criteria for malignant lymphoma. Efficacy based on overall response rate (ORR) was assessed by an Independent Review Committee. Efficacy results from CHRONOS-1 are summarized in Table 5.
Table 5: Overall Response Rate (ORR) and Duration of Response (DOR) in Patients with Relapsed Follicular Lymphoma
ALIQOPA
N=104
ORR, n (%)
61 (59%)
(95% CI)
(49, 68)
CR, n (%)
15 (14%)
PR, n (%)
46 (44%)
Median* DOR, months (range)
12.2 (0+, 22.6)
ORR = overall response rate; CI = confidence interval; CR = complete response;
PR = partial response; DOR = duration of response
*Kaplan-Meier estimate
The median time to response was 1.7 months (range 1.3 to 9.7 months).
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
ALIQOPA is contained in a colorless glass vial closed with bromobutyl stopper with a flanged closure. Each vial of ALIQOPA contains copanlisib as a lyophilized solid.
NDC
Strength
Reconstituted Concentration
50419-385-01
60 mg
(one single-dose vial per carton)
15 mg/mL
16.2 Storage and Handling
Product as packaged for sale
ALIQOPA vials must be refrigerated at 2°C to 8°C (36°F to 46°F).
Product after reconstitution
Administer reconstituted and diluted solution immediately. If not, refrigerate at 2°C to 8°C (36°F to 46°F) and use within 24 hours. After refrigeration, allow the product to adapt to room temperature before use. Avoid exposure of the diluted solution to direct sunlight.
Mix only with 0.9% NaCl solution. Do not mix or inject ALIQOPA with other drugs or other diluents [see Dosage and Administration (2.3, 2.4)].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
• Infections – Advise patients that ALIQOPA can cause serious infections that may be fatal. Advise patients to immediately report symptoms of infection [see Warnings and Precautions (5.1)]. • Hyperglycemia – Advise patients that an infusion-related increase in blood glucose may occur, and to notify their healthcare provider of any symptoms such as pronounced hunger, excessive thirst, headaches, or frequently urinating. Blood glucose levels should be well controlled prior to infusion [see Warnings and Precautions ( 5.2 )]. • Hypertension – Advise patients that an infusion-related increase in blood pressure m
