Switching Capsule Formulation
Beginning the month of_____, IBRANCE will be switching from capsule formulation to tablets
What is April?
The most frequently reported adverse reaction in Study 1 is_____________________
What is Neutropenia?
The PALOMA-2 is a___, ______, _________, ______ Trial
What are 2:1, Randomized, Double-Blind, Phase 3?
The following were secondary endpoints in PALOMA-3 study.
What is Clinical Benefit Rate, Duration of Response, and Overall Survival
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, Safety, and Tolerability
What __ % Patients in the IBRANCE=fulvestrant had previous chemotherapy for treatment of metastatic disease (with or without adjuvant or neoadjuvant)
What is 33%?
The new NCCN recommendations for Palbociclib we can share with our customers are_________.
What is nothing (We currently can't share any recommendations).
HCPs should specify _______ _________ on all IBRANCE prescriptipons.
What is IBRANCE tablets?
The recommended starting dose of IBRANCE and schedule
What is 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to complete a 28 day cycle
What __ % Patients in the IBRANCE+Letrozole had previous chemotherapy treatment
What is 48%?
In both treatment groups of PAL 3, 79% of patients were _______ and 21% of patients were ________; the majority of patients had received _____ previous line(s) of endocrine treatment.
What is postmenopausal and peri/premenopausal, and 1?
Permanently discontinue IBRANCE for severe ______and _________.
What are ILD and Pneumonitis?
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 and 6% for Study 2?
This _% of patients included in PAL-2 had DFI of <12 months and __% had 3 or more sites
What are 22% and 42.6%?
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?