pies. All 106 patients received Rubraca 600 mg orally twice daily as monotherapy until disease progression or unacceptable toxicity. Objective response rate (ORR) and duration of response (DOR) were assessed by the investigator and independent radiology review (IRR) according to Response eva luation Criteria in Solid Tumors (RECIST) version 1.1.
The median age of the patients was 59 years (range 33 to 84), the majority were Caucasian (78%), and 100% had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. All patients had received at least two prior platinum-based chemotherapies and 43% had received 3 or more prior lines of chemotherapy. There were 18/106 patients (17%) who had deleterious BRCA mutations detected in tumor tissue and not in whole blood specimens. Tumor BRCA mutation status was verified retrospectively in 96% (64/67) of the patients for whom a tumor tissue sample was available by the companion diagnostic FoundationFocus™ CDxBRCA test, which is FDA approved for selection of patients for Rubraca treatment.
Efficacy results are summarized in TABLE 4.
Table 4. Overall Response and Duration of Response in Patients with BRCA-mutant Ovarian Cancer Who Received 2 or More Chemotherapies in Study 1 and Study 2
Investigator-assessed
N=106
Objective Response Rate (95% CI) 54% (44, 64)
Complete Response 9%
Partial Response 45%
Median DOR in months (95% CI) 9.2 (6.6, 11.6)
Response assessment by independent radiology review was 42% (95% CI [32, 52]), with a median DOR of 6.7 months (95% CI [5.5, 11.1]). Investigator-assessed ORR was 66% (52/79; 95% CI [54, 76]) in platinum-sensitive patients, 25% (5/20; 95% CI [9, 49]) in platinum-resistant patients, and 0% (0/7; 95% CI [0, 41]) in platinum-refractory patients. ORR was similar for patients with a BRCA1 gene mutation or BRCA2 gene mutation.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Rubraca is available as 200 mg, 250 mg, and 300 mg tablets.
200mg Tablets:
Blue, round, and debossed with “C2” on one side
Supplied in bottles of 60 tablets (NDC: 69660-201-91)
250mg Tablets:
White, diamond, and debossed with “C25” on one side
Supplied in bottles of 60 tablets (NDC: 69660-202-91)
300mg Tablets:
Yellow, oval, and debossed with “C3” on one side
Supplied in bottles of 60 tablets (NDC: 69660-203-91)
16.2 Storage
Store at 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].
CLOSE
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION).
MDS/AML: Advise patients to contact their healthcare provider if they experience weakness, feeling tired, fever, weight loss, frequent infections, bruising, bleeding easily, breathlessness, blood in urine or stool, and/or laboratory findings of low blood cell counts, or a need for blood transfusions. These may be signs of hematological toxicity or a more serious uncommon bone marrow problem called ‘myelodysplastic syndrome' (MDS) or ‘acute myeloid leukemia' (AML) which have been reported in patients treated with Rubraca [see Warnings and Precautions (5.1)].
Embryo-Fetal Toxicity: Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to a fetus and potential loss of the pregnanc |
