Novartis receives FDA approval of Farydak®, the first HDAC inhibitor for patients with multiple myeloma
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Novartis International AG /
Novartis receives FDA approval of Farydak®, the first HDAC inhibitor for
patients with multiple myeloma
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The issuer is solely responsible for the content of this announcement.
* Farydak, an HDAC inhibitor with epigenetic activity, approved in combination
for patients who received at least two prior regimens including bortezomib
and IMiD[1]
* Farydak prolonged median PFS benefit when used with bortezomib and
dexamethasone combination versus combination alone (from 6 to 11 months)[1]
* Multiple myeloma is an incurable blood cancer and there is an urgent need
for new treatments[2]
* Farydak is approved under FDA's accelerated approval program; regulatory
applications are underway in the EU, Japan and worldwide
The digital press release with multimedia content can be accessed here:
Basel, February 23, 2015 - Novartis announced today that the US Food and Drug
Administration (FDA) has approved Farydak(®) (panobinostat, previously known as
LBH589) capsules in combination with bortezomib* and dexamethasone for the
treatment of patients with multiple myeloma who have received at least two prior
regimens, including bortezomib and an immunomodulatory (IMiD) agent[1].
"Farydak represents an exciting agent with a new mechanism of action that is
part of a promising class of drugs in this setting," said study investigator
Paul Richardson, MD, Clinical Program Leader and Director of Clinical Research,
Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute.
"Importantly, Farydak has been shown to improve progression-free survival in
relapsed multiple myeloma patients who have received at least two prior
regimens, including bortezomib and an IMiD, which is an area of particular unmet
medical need."
Farydak has been shown to extend the progression-free survival (PFS) benefit of
the standard-of-care therapy in this patient population[1]. Farydak is approved
under accelerated approval based on PFS[1]. Continued approval for this
indication may be contingent upon verification and description of clinical
benefit in confirmatory trials. The FDA's accelerated approval program gives
patients access to treatments for serious or life-threatening illnesses that
provide meaningful therapeutic benefit over existing treatments. The FDA has
approved a risk evaluation and mitigation strategy (REMS) for Farydak. The REMS
program serves to inform and educate healthcare professionals about the risks
that may be associated with Farydak treatment.
This FDA approval is based on efficacy and safety data in a pre-specified
subgroup analysis of 193 patients who had received prior treatment with both
bortezomib and an IMiD during the Phase III, randomized, double-blind, placebo-
controlled, multicenter global registration trial, called PANORAMA-1
(PANobinostat ORAl in Multiple MyelomA)[1]. The trial found that the median PFS
benefit increased in Farydak patients who had received prior treatment with both
bortezomib and an IMiD (10.6 months; n=94), as compared to the placebo arm (5.8
months; n=99) (hazard ratio=0.52 [95% confidence interval (CI): 0.36, 0.76])[1].
The most common adverse reactions (incidence >= 20%) in clinical studies are
diarrhea, fatigue, nausea, peripheral edema, decreased appetite, pyrexia and
vomiting[1]. The most common non-hematologic laboratory abnormalities (incidence
/>= 40%) are hypophosphatemia, hypokalemia, hyponatremia and increased
creatinine[1]. The most common hematologic laboratory abnormalities (incidence
/>= 60%) are thrombocytopenia, lymphopenia, leukopenia, neutropenia and
anemia[1]. Farydak can cause fatal and serious toxicities including severe
diarrhea and cardiac toxicities. Severe diarrhea occurred in 25% of Farydak-
treated patients. Severe and fatal cardiac ischemic events, including severe
arrhythmias and ECG changes have occurred in patients receiving Farydak. Serious
adverse events (SAEs) occurred in 60% of patients treated with Farydak,
bortezomib and dexamethasone compared to 42% of patients in the control arm. The
most frequent (>= 5%) treatment-emergent SAEs reported for patients treated with
Farydak were pneumonia (18%), diarrhea (11%), thrombocytopenia (7%), fatigue
(6%) and sepsis (6%). Additional serious adverse reactions included hemorrhage,
myelosuppression, infections, hepatotoxicity and embryo-fetal toxicity[1].
"Novartis is committed to developing innovative first-in-class therapies for
patients who need treatment options," said Bruno Strigini, President, Novartis
Oncology. "Farydak represents a new drug class in multiple myeloma, providing
these patients with an important treatment approach for this difficult-to-treat
cancer."
Farydak is the first histone deacetylase (HDAC) inhibitor available to patients
with multiple myeloma[3]. As an HDAC inhibitor, its epigenetic activity may help
to restore cell function in multiple myeloma[4].
Additional regulatory submissions for Farydak are being reviewed by health
authorities worldwide.
About multiple myeloma
Epigenetics is the cell programming that governs gene expression and cell
development[3]. In multiple myeloma, the normal epigenetic process is disrupted
(also called epigenetic dysregulation) resulting in the growth of cancerous
plasma cells, potential resistance to current treatment, and ultimately disease
progression[5],[6].
Multiple myeloma impacts approximately 1 to 5 in every 100,000 people
globally[7]. Multiple myeloma is a cancer of the plasma cells, a kind of white
blood cell present in bone marrow-the soft, blood-producing tissue that fills
the center of most bones. The cancer is caused by the production and growth of
abnormal cells within the plasma, which multiply and build up in the bone
marrow, pushing out healthy cells and preventing them from functioning
normally[8]. Multiple myeloma is an incurable disease with a high rate of
relapse (when the cancer returns) and resistance (when the therapy stops
working), despite currently available treatments[2]. It typically occurs in
individuals 60 years of age or older, with few cases in individuals younger than
40[9].
Farydak(®) Important Safety Information
Farydak can cause serious side effects, including diarrhea and heart problems.
Diarrhea is common with Farydak and can be severe. Patients should tell their
healthcare provider (HCP) right away if they have abdominal (stomach) cramps,
loose stool, diarrhea, or feel like they are becoming dehydrated. HCPs may
prescribe medicines to help prevent or treat these side effects. Taking or using
stool softeners or laxative medicines may worsen diarrhea, patients should talk
to their HCP before taking or using these medicines.
Farydak can cause severe heart problems which can lead to death. Risk of heart
problems may be increased with a condition called "long QT syndrome" or other
heart problems. Patients should call their HCP and get emergency medical help
right away if they have any of the following symptoms of heart problems: chest
pain, faster or slower heart beat, palpitations (feel like heart is racing),
feel lightheaded or faint, dizziness, blue colored lips, shortness of breath, or
swelling in legs.
Farydak can cause severe bleeding which can lead to death. It may take patients
longer than usual to stop bleeding while taking Farydak. Patients should tell
their HCP right away if they get any of the following signs of bleeding: blood
in stools or black stools (look like tar), pink or brown urine, unexpected
bleeding or bleeding that is severe or that cannot be controlled, vomit blood or
vomit looks like coffee grounds, cough up blood or blood clots, increased
bruising, feeling dizzy or weak, confusion, change in speech, or headache that
lasts a long time.
Farydak is a prescription medicine used, in combination with bortezomib and
dexamethasone, to treat people with a type of cancer called multiple myeloma
after at least two other types of treatment have been tried. It is not known if
Farydak is safe and effective in children.
Patients should tell their HCP about all of the medicines they take, including
prescription and over-the-counter medicines, vitamins and herbal supplements.
Patients should take Farydak exactly as the HCP tells them to take it. The HCP
will tell patients how much Farydak to take and when to take it. The HCP may
change the dose or stop treatment temporarily if patients experience side
effects. Patients should not change the dose or stop taking Farydak without
first talking with their HCP.
Patients should avoid eating star fruit, pomegranate or pomegranate juice, and
grapefruit or grapefruit juice while taking Farydak. These foods may affect the
amount of Farydak in the blood.
Low blood cell counts are common with Farydak and can be severe. Low platelet
count (thrombocytopenia) can cause unusual bleeding or bruising under the skin.
Low white blood cell count (neutropenia) can cause infections. Low red blood
cell count (anemia) may make a patient feel weak, tired, or they may get tired
easily, look pale, or feel short of breath.
There is an increased risk of infection while taking Farydak. Patients should
contact their HCP right away if they have a fever or have any signs of an
infection including sweats or chills, cough, flu-like symptoms, shortness of
breath, blood in phlegm, sores on body, warm or painful areas on body, or
feeling very tired.
Patients should call their HCP right away with any of the following symptoms of
liver problems: feel tired or weak, loss of appetite, dark amber colored urine,
upper abdominal pain, yellowing of skin or the white of eyes.
The most common side effects of Farydak include tiredness, nausea, swelling in
arms or legs, decreased appetite, fever and vomiting. Patients should tell their
HCP if they have any side effect that is bothersome or that does not go away.
Please see full Prescribing Information, including Boxed WARNING, for Farydak(®)
(panobinostat) capsules.
Outside of the US, Farydak (LBH589) is an investigational agent and has not been
approved by regulatory authorities.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "underway," "exciting," "promising," "committed," "being
reviewed," "may," "contingent," "investigational," or similar terms, or by
express or implied discussions regarding potential future marketing approvals
for Farydak, or regarding potential future revenues from Farydak. You should not
place undue reliance on these statements. Such forward-looking statements are
based on the current beliefs and expectations of management regarding future
events, and are subject to significant known and unknown risks and
uncertainties. Should one or more of these risks or uncertainties materialize,
or should underlying assumptions prove incorrect, actual results may vary
materially from those set forth in the forward-looking statements. There can be
no guarantee that Farydak will be approved for sale in any market where it has
been submitted, or at any particular time. Neither can there be any guarantee
that Farydak will be submitted or approved for any additional indications or
labeling in any market, or at any particular time. Nor can there be any
guarantee that Farydak will be commercially successful in the future. Continued
approval of Farydak in the approved indication may be contingent upon
verification and description of clinical benefit in confirmatory trials. In
particular, management's expectations regarding Farydak could be affected by,
among other things, unexpected regulatory actions or delays or government
regulation generally; the uncertainties inherent in research and development,
including unexpected clinical trial results and additional analysis of existing
clinical data; the company's ability to obtain or maintain proprietary
intellectual property protection; general economic and industry conditions;
global trends toward health care cost containment, including ongoing pricing
pressures; unexpected manufacturing issues, and other risks and factors referred
to in Novartis AG's current Form 20-F on file with the US Securities and
Exchange Commission. Novartis is providing the information in this press release
as of this date and does not undertake any obligation to update any forward-
looking statements contained in this press release as a result of new
information, future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and over-the-
counter products. Novartis is the only global company with leading positions in
these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while
R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6
billion excluding impairment and amortization charges). Novartis Group companies
employ approximately 130,000 full-time-equivalent associates. Novartis products
are available in more than 180 countries around the world. For more information,
please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
[1] Full Prescribing Information.
[2] The Leukemia and Lymphoma Society. Myeloma. Revised 2013;1:48.
[3] Grønbæk K, Treppendahl M, Asmarand F, Guldberg P. Epigenetic Changes in
Cancer as Potential Targets for Prophylaxis and Maintenance Therapy. Basic &
Clinical Pharmacology & Toxicology. 2008;103:389-396.
[4] Maes K, et al. Epigenetic Modulating Agents as a New Therapeutic Approach in
Multiple Myeloma. Cancers. 2013;5:430-461.
[5] Smith EM, Boyd K, Davies FE. The Potential Role of Epigenetic Therapy in
Multiple Myeloma. Br J Haematol. 2009;148:702-713.
[6] Muntean AG, Hess JL. Epigenetic Dysregulation in Cancer. Am J Pathol.
2009;175:1353-1361.
[7] Parkin M, et al. Global Cancer Statistics, 2002. CA Cancer J Clin.
2005;55:74-108.
[8] American Cancer Society. Multiple Myeloma. Available at:
http://www.cancer.org/acs/groups/cid/documents/webcontent/003121-pdf.pdf.
Accessed July 2014.
[9] National Cancer Institute. SEER Stat Fact Sheets: Myeloma. Available at:
http://seer.cancer.gov/statfacts/html/mulmy.html. Accessed July 2014.
* Trade name Velcade(® )registered to Millennium Pharmaceuticals, Inc.
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Datum: 23.02.2015 - 21:19 Uhr
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