iteria in Solid Tumors (RECIST) version 1.1, as assessed by blinded independent central review (BICR). A statistically significant improvement in PFS was demonstrated for TALZENNA compared with chemotherapy. A sensitivity analysis of investigator-assessed PFS was consistent with the BICR-assessed PFS results. Consistent PFS results were observed across patient subgroups defined by study stratification factors (line of therapy, TNBC status, and history of CNS metastases). The overall survival (OS) data were not mature at the time of the final PFS analysis (38% of patients had died). Efficacy data from the EMBRACA study are summarized in Table 5, and the Kaplan-Meier curves for PFS are shown in Figure 1.
Table 5. Summary of Efficacy Results – EMBRACA Study
TALZENNA Chemotherapy
Abbreviations: BICR=blinded independent central review; CI=confidence interval.
*
Hazard ratio is estimated from a Cox proportional hazards model stratified by prior use of chemotherapy for metastatic disease (0 versus 1, 2, or 3), by triple-negative disease status (triple-negative breast cancer [TNBC] versus non TNBC), and by history of central nervous system metastasis (yes versus no).
†
P-values from stratified log-rank test (2-sided).
‡
Conducted in intent-to-treat (ITT) population with measurable disease at baseline.
§
Response rate based on confirmed responses.
¶
Median estimated from Kaplan-Meier probabilities.
Progression-Free Survival by BICR N=287 N=144
Events, number (%) 186 (65) 83 (58)
Median months (95% CI) 8.6 (7.2, 9.3) 5.6 (4.2, 6.7)
Hazard Ratio (95% CI)* 0.54 (0.41, 0.71)
p-value† p<0.0001
Patients with Measurable Disease by Investigator‡ N=219 N=114
Objective Response Rate, % (95% CI)§ 50.2 (43.4, 57.0) 18.4 (11.8, 26.8)
Duration of Response Median¶ months (95% CI) 6.4 (5.4, 9.5) 3.9 (3.0, 7.6)
Figure 1. Kaplan-Meier Curves of PFS – EMBRACA Study
Figure 1
16 HOW SUPPLIED/STORAGE AND HANDLING
TALZENNA is supplied in strengths and package configurations as described in Table 6:
Table 6. TALZENNA Capsules
Package Configuration Capsule Strength (mg) NDC Print
Bottles of 30 capsules 0.25 NDC: 0069-0296-30 Ivory cap (printed with "Pfizer" in black) and a white body (printed with "TLZ 0.25" in black).
Bottles of 30 capsules 1 NDC: 0069-1195-30 Light red cap (printed with "Pfizer" in black) and a white body (printed with "TLZ 1" in black).
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
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. This may be a sign of hematological toxicity or a more serious uncommon bone marrow problem called MDS or AML, which have been reported in p |
