Switching Capsule Formulation
Beginning the month of_____, IBRANCE will be switching from capsule formulation to tablets
What is April?
Three of the four most frequently reported adverse reactions in Study 1 are_____________________
What are Neutropenia, Infections, Leukopenia, and Fatigue?
The PALOMA-2 is a___, ______, _________, ______ Trial
What are 2:1, Randomized, Double-Blind, Phase 3?
The %_______ of patients who were pre-/peri-menopausal at baseline in PAL-3
What is 20.7%
What was month ____ and year____ was IBRANCE approved
What are the February and 2015?
IBRANCE may be taken_________
What is With or Without Food?
In Study 1 and Study 2 the median time to the first episode of any grade neutropenia was ____ and the median duration of _____.
What is 15 days and 7 days?
The PALOMA -2 Secondary Endpoints are _________
What are Overall Survival, Overall Response Rate, Health-Related Quality of Life, Safety, and Tolerability
The _____ % of patients in PAL-3 who had greater than or equal to 3 lines of therapy in the metastatic setting at baseline.
What is 11.8%?
In the updated non-prespecified PFS analyses from PAL-2 in patients with bone-only disease, the PFS for those patients was this _______.
36.2 months (placebo?)
HCPs should specify _______ _________ on all IBRANCE prescriptions.
What is IBRANCE tablets?
The Warnings and Precautions listed in the IBRANCE PI are ______________
What are Neutropenia, Interstitial Lung Disease/Pneumonitis, and Embyo-fetal toxicity?
What _____ % Patients in PAL-2 discontinued IBRANCE due to Neutropenia and what _______% of patients had a dose reduction due to an AR of any grade?
What is 1.1% and 36%?
The %________ of patients who received IBR/Fulv in 1L in PAL-3
What is24.2%
In the updated non-prespecified PFS analyses from PAL-2, the PFS was this________ for patients who were greater than or equal to 65 years old.
What is 30.6 months (vs. ? for placebo?)
IBRANCE tablets are received in and must be stored in _______ ________
What are blister packs?
Monitor _______ prior to the start of IBRANCE therapy and at the beginning of each cycle, as well as on ________, and as clinically indicated.
What is CBC, and Day 15 of the first 2 cycles
In the PAL 2 the median PFS was __ in the IBRANCE+Letrozole group and __ in the Pacebo+Letrozole group
What are 24.8 Months and 14.5 Months
In PAL 3, the median PFS as assessed by the investigators in the ITT population was __ months in the IBRANCE+fulvestrant group and __ months in the placebo+fulvestrant group
What is 9.5 and 4.6?
From Study 1 (PAL-2) and Study 2 (PAL-3) what are two highest % lab abnormalities.
What are WBCs and Neutrophils Decreased?
IBRANCE switching from capsules to tablets offers patients the following three key benefits:
What is Increased Flexibility, Dose Tracking, and Addresses Dietary Restrictions?
Permanent discontinuation associated with an adverse reaction occurred __% in Study 1 and __% in Study 2
What is 9.7% for Study 1 (vs. ? Placebo) and 6% for Study 2 (vs. ? Placebo)?
This ______% of patients included in PAL-2 had a DFI of <12 months.
What are 22.3%?
In the PAL 3 the median OS was __ in the IBRANCE + fulvestrant group and __ in the Pacebo+fulvestrant group
What is 34.9 months and 28 months?
The key pillars (boxes) of the Winning Formula are?
What are Experience, Efficacy, Safety/Monitoring, and Access/Support?