emember the days of
er launches? Then you
must be getting old. Just
like the new compounds
that launched in 2013 and 2014, the
top sellers among the NMEs introduced
in the United States during 2015 are
all specialty drugs. In fact, of the top
ten 2016 revenue producers from the
new compound class of 2015, only one
– Otsuka Pharmaceutical and Lund-
beck’s atypical antipsychotic Rexulti
– might not be called a specialty medi-
cine (depending, of course, on who you
ask). And while the numbers are not as
spectacular as Sovaldi’s or Harvoni’s,
three members of the new compound
class of 2015 earned more than a billion
dollars in sales in their first full year on
the market, with Pfizer’s Ibrance gen-
erating more than $2 billion. Unlike So-
valdi and Harvoni, though, these three
continue to grow.
First approved on an accelerated basis
in February 2015, Pfizer’s breast cancer
drug Ibrance earned $723 million in rev-
enue that year and an impressive $2.14
billion in 2016, making it the leader of
the new compound Class of 2015 and
the largest single brand source of reve-
nue growth in Pfizer’s entire portfolio.
According to a report by the market re-
search company Statista, Ibrance will
be the seventh highest-selling oncology
drug in the world by 2020, with project-
ed sales that year of $4.7 billion.
In February 2016 FDA approved a
supplemental NDA expanding the use
of Ibrance 125 milligram capsules to
include the treatment of hormone re-
first year after launch specialfeature
The specialties win again
Just like last year and the year before, specialty drugs dominate this year’s
list of top performers in the most recent ;rst year after launch class.
We asked Adrienne Morgan and Geetiksa
Prasad, the account and copy leads for
Ibrance at H4B Chelsea, about their agency’s
work with P;zer’s star breast cancer brand.
What do you think the most innovative component of the
Ibrance campaign has been, and why?
The most innovative component of the Ibrance campaign is
surprisingly simple: the beam artwork. Not for the obvious reason
of being an icon that communicates female empowerment and
combination therapy, but for being a foundational and ;exible
design element we’ve been able to evolve over time. When the
Ibrance + fulvestrant indication was approved in 2016, we leveraged the beams to create the cover of a journal ad that was exciting, new, and inviting. We reinvented the beams but maintained
continuity with the campaign since this journal ad ran only a year
after launch. Our latest campaign iteration has completely new
copy and a new background, showcasing that the MBC landscape
is changing, but ;rst-in-class Ibrance is here to stay.
Separately, we created campaign to celebrate the 2-year anniversary of Ibrance’s launch. We knew competitors were coming and
wanted to make sure that Ibrance was recognized as the pioneer
of CDK4/6 inhibitors. The rich purple and bright green colors paid
homage to the launch campaign without using the beams. Two
years may not feel like a long time, but when you’re talking about
helping thousands and thousands of women, it’s never too soon.
As Mike Tyson once said, “Everyone has a plan until they get
hit.” What key adjustments were made to the Ibrance cam-
paign post-launch, once all the data started pouring in? What
would you say the biggest post-market surprises were, and
how did you respond to them?
Ibrance essentially relaunched every year for the ;rst two years
after launch. More data meant more label updates, and we updated the campaign every time. The ;rst iteration featured a new
headline and a reinvented use of the beams. The second iteration
featured another new and improved headline as well as a new
background design for the campaign.
An interesting surprise soon after launch was learning that
oncologists considered Ibrance to be chemotherapy. We heard
it casually at market research and also in feedback from the sales
force. Though we understood where that misunderstanding came
from, we needed to rectify it quickly. Some immediate changes
included simplifying our MOA story and incorporating messages
that helped distinguish Ibrance from chemotherapy. We also went
beyond promotion to arm the reps with smart ways to engage in
compliant conversations that helped the oncologists appreciate
just how unique Ibrance is.
Another surprise was the expanded approval Ibrance received
when the label was updated a second time. We needed to
announce this approval even though the bigger news was that
we now had ;rst-line Phase III data. Our solution was to incorporate the expanded approval messaging into our core story while
keeping the overall focus on trial results.
Talk about the relationship between the agency and P;zer
Oncology. What made it work so well? What challenges did
you face? What lessons have you learned?
We’re fortunate to work with a group of marketers who appreciate
the expertise an agency brings. Our clients see us as partners,
which is critical to our success to date. Finding opportunities to
collaborate – both within the walls of P;zer and across di;erent
agencies – showcased our ability to be an outstanding partner. The
kind of partner who’s there to celebrate the good times and make
the most of the not-so-good times.
The learning curve for us when we ;rst took over the business
was very steep. The marketing team had already invested years
into Ibrance and we were clearly the new kids on the block. We
quickly learned how to provide creative suggestions and solutions
even when history may have precluded creativity from being
an option. We turned being the newbies into a strength and an
opportunity to do more.
And ;nally, we have a respectful and friendly rapport with our
clients. We can talk shop just as easily as we can talk about things
outside of work, which adds an ease and comfort to our working
What are a couple of key elements that all great launches, big
or small, share?
For us a great launch is de;ned by three important elements: noticeable brand presence, excitement in the industry, and impact on
the market. Whether you’re ;rst to market or ;fth to market, your
brand has to stand out. A successful launch is one where the name,
look, feel, and expression of a brand are strong and memorable
enough to distinguish the brand.
Launching is all about creating a buzz. When healthcare professionals get truly excited about the possibilities of a therapy – the results can be amazing. Of course there are HCPs who are set in their
ways or hesitant to try something new, but when you can leverage
the curiosity and con;dence of HCPs, you create an environment
where a brand can succeed.
A successful launch fundamentally changes how the market
approaches treatment. One clear shift we noticed with Ibrance was
that, for the ;rst time in over a decade, HCPs expected more for
their patients with metastatic breast cancer. We knew KOLs were
starting to describe MBC as a chronic condition, and that meant
we could help other HCPs recognize that Ibrance was changing
the game in MBC. HCPs were reconsidering their treatment approach. They were questioning if there really was more they could
do for these patients. And in the end, they were revamping their
overall treatment approach so their MBC patients could experience superior outcomes.
How have you kept things fresh for key stakeholders beyond
your target HCPs?
It’s important to keep the sales force excited about the brand,
and sometimes people can lose sight of that. After a year of the
traditional rep training materials, we shook things up with an
internal initiative that featured a fresh new design and leveraged a
cool and playful tone. We wanted to make sure reps were engaged
throughout the process of learning, because Ibrance had new data
and information coming out every few months. By having fun with
the creative process, we infused fun into the rep training experience. And the sales force loved it.
So what’s next for Ibrance?
Our next step is all about staying a step ahead of our competitors.
Ibrance will soon be one of three CDK4/6 inhibitors available for HCPs.
Based on its own merits, Ibrance is a blockbuster in MBC – but now
we have to make sure it stands up to the impending competition.
Please see Important Safety Information
IBRANCE® (palbociclib) is indicated for the treatment of hormone receptor-positive (HR+), human epidermal
growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with:
• letrozole as initial endocrine-based therapy in postmenopausal women, or
• fulvestrant in women with disease progression following endocrine therapy
The indication in combination with letrozole is approved under accelerated approval based on progression-free
survival (PFS). Continued approval for this indication may be contingent upon verification and description of
clinical benefit in a confirmatory trial.
Recommended treatment option by the
National Comprehensive Cancer Network® (NCCN®)1
palbociclib (IBRANCE) + fulvestrant
for postmenopausal women or for premenopausal women
receiving an LHRH agonist, with HR+/HER2- MBC that has
progressed on endocrine therapy (category 1)†
palbociclib (IBRANCE) + letrozole
for first-line treatment of
postmenopausal women with
HR+/HER2- MBC (category 2A)*
Important Safety Information
Neutropenia was the most frequently reported adverse reaction in Study 1 (75%) and Study 2 (83%). In Study 1,
Grade 3 (57%) or 4 (5%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole.
In Study 2, Grade 3 (56%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving
IBRANCE plus fulvestrant. Febrile neutropenia has been reported in about 1% of patients exposed to IBRANCE.
One death due to neutropenic sepsis was observed in Study 2. Inform patients to promptly report any fever.
Monitor complete blood count prior to starting IBRANCE, at the beginning of each cycle, on Day 14 of first 2
cycles, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles
is recommended for patients who develop Grade 3 or 4 neutropenia.
NOW FOR MORE PATIEN TS WI TH ME TAS TATIC BREAS T CANCER (MBC)
LHRH=luteinzing hormone-releasing hormone.
*Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.1
†Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.1
IBRANCE + letrozole or fulvestrant
Two approved combination options for a range of women with HR+/HER2- MBC
Please see Important Safety Information throughout,followed by Brief Summary.
Grade 3/4 adverse reactions (≥10%) in PALOMA-1 reported
at a higher incidence in the IBRANCE plus letrozole group vs
the letrozole alone group included neutropenia (54% vs 1%)
and leukopenia (19% vs 0%). The most frequently reported
serious adverse events in patients receiving IBRANCE plus
letrozole were pulmonary embolism (4%) and diarrhea (2%).
Lab abnormalities occurring in PALOMA-1 (all grades,
IBRANCE plus letrozole vs letrozole alone) were decreased
WBC (95% vs 26%), decreased neutrophils (94% vs 17%),
decreased lymphocytes (81% vs 35%), decreased hemoglobin
(83% vs 40%), and decreased platelets (61% vs 16%).
The most common adverse reactions (≥10%) of any grade
reported in PALOMA- 3 of IBRANCE plus fulvestrant vs
fulvestrant plus placebo included neutropenia (83% vs 4%),
leukopenia (53% vs 5%), infections (47% vs 31%), fatigue
(41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%),
stomatitis (28% vs 13%), headache (26% vs 20%), diarrhea
(24% vs 19%), thrombocytopenia (23% vs 0%), constipation
(20% vs 16%), vomiting (19% vs 15%), alopecia (18% vs 6%),
rash (17% vs 6%), decreased appetite (16% vs 8%), and
pyrexia (13% vs 5%).
Grade 3/4 adverse reactions (≥10%) in PALOMA- 3 reported
at a higher incidence in the IBRANCE plus fulvestrant group
vs the fulvestrant plus placebo group included neutropenia
(66% vs 1%) and leukopenia (31% vs 2%). The most frequently
reported serious adverse reactions in patients receiving
IBRANCE plus fulvestrant were infections (3%), pyrexia (1%),
neutropenia (1%), and pulmonary embolism (1%).
Lab abnormalities occurring in PALOMA- 3 (all grades,
IBRANCE plus fulvestrant vs fulvestrant plus placebo) were
decreased WBC (99% vs 26%), decreased neutrophils
(96% vs 14%), anemia (78% vs 40%), and decreased platelets
(62% vs 10%).
Avoid concurrent use of strong CYP3A inhibitors. If patients
must be administered a strong CYP3A inhibitor, reduce
the IBRANCE dose to 75 mg/day. If the strong inhibitor is
discontinued, increase the IBRANCE dose (after 3-5 half-lives
of the inhibitor) to the dose used prior to the initiation of the
strong CYP3A inhibitor. Grapefruit or grapefruit juice may
increase plasma concentrations of IBRANCE and should be
avoided. Avoid concomitant use of strong CYP3A inducers.
The dose of sensitive CYP3A substrates with a narrow
therapeutic index may need to be reduced as IBRANCE may
increase their exposure.
IBRANCE has not been studied in patients with moderate to
severe hepatic impairment or in patients with severe renal
impairment (CrCl < 30 mL/min).
Please see Brief Summary on the following pages.
IBRANCE is indicated for the treatment of hormone
receptor-positive (HR+), human epidermal growth factor
receptor 2-negative (HER2-) advanced or metastatic
breast cancer (MBC) in combination with:
postmenopausal women, or
• fulvestrantin women withdiseaseprogression
following endocrine therapy
The indication in combination with letrozole is approved
under accelerated approval based on progression-free
survival (PFS). Continued approval for this indication may
be contingent upon verification and description of clinical
benefit in a confirmatory trial.
Important Safety Information
Neutropenia was the most frequently reported adverse
reaction in PALOMA-1 (75%) and PALOMA- 3 (83%).
In PALOMA-1, Grade 3 (57%) or 4 (5%) decreased neutrophil
counts were reported in patients receiving IBRANCE plus
letrozole. In PALOMA- 3, Grade 3 (56%) or Grade 4 (11%)
decreased neutrophil counts were reported in patients
receiving IBRANCE plus fulvestrant. Febrile neutropenia has
been reported in about 1% of patients exposed to IBRANCE.
One death due to neutropenic sepsis was observed in
PALOMA- 3. Inform patients to promptly report any fever.
Monitor complete blood count prior to starting IBRANCE, at
the beginning of each cycle, on Day 14 of first 2 cycles, and as
clinically indicated. Dose interruption, dose reduction, or delay
in starting treatment cycles is recommended for patients who
develop Grade 3 or 4 neutropenia.
Pulmonary embolism (PE) has been reported at a higher rate
in patients treated with IBRANCE plus letrozole in PALOMA-1
(5%) and in patients treated with IBRANCE plus fulvestrant
in PALOMA- 3 (1%) compared with no cases in patients treated
either with letrozole alone or fulvestrant plus placebo.
Monitor for signs and symptoms of PE and treat as
Based on the mechanism of action, IBRANCE can cause
fetal harm. Advise females of reproductive potential to use
effective contraception during IBRANCE treatment and for
at least 3 weeks after the last dose. IBRANCE may impair
fertility in males and has the potential to cause genotoxicity.
Advise male patients with female partners of reproductive
potential to use effective contraception during IBRANCE
treatment and for 3 months after the last dose. Advise females
to inform their healthcare provider of a known or suspected
pregnancy. Advise women not to breastfeed during IBRANCE
treatment and for 3 weeks after the last dose because of the
potential for serious adverse reactions in nursing infants.
The most common adverse reactions (≥10%) of any grade
reported in PALOMA-1 of IBRANCE plus letrozole vs letrozole
alone included neutropenia (75% vs 5%), leukopenia
(43% vs 3%), fatigue (41% vs 23%), anemia (35% vs 7%),
upper respiratory infection (31% vs 18%), nausea (25% vs 13%),
stomatitis (25% vs 7%), alopecia (22% vs 3%), diarrhea
(21% vs 10%), thrombocytopenia (17% vs 1%), decreased appetite
(16% vs 7%), vomiting (15% vs 4%), asthenia (13% vs 4%),
peripheral neuropathy (13% vs 5%), and epistaxis (11% vs 1%).
AU NT AU N
N TA UN
DOCTOR DOCTOR DOCTOR DOCTOR DOCTOR
DOCTORDOCTORDOCTORDOCTORDOCTORDAUGHTER DAUGHTER DAUGHTER
ONCOLOGIST ONCOLOGIST ONCOLOGIST
SISTER SISTER SISTER SISTER SISTER SISTER
2 years of milestones.
So many lives touched.
Your commitment to your patients and their loved ones continues to inspire us.
Since FDA approval, IBRANCE® (palbociclib) has reached several important milestones, including
being prescribed by [X,XXX]+ oncologists for [XX,XXX]+ patients.1* As experience with IBRANCE
continues to grow, so does our commitment to you and your patients.
To learn more about IBRANCE and other milestones, like recently published
Phase 3 data, visit IBRANCEhcp.com
*Data current as of [Month Year].