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ots-News: English

FDA Accepts sBLA and Grants Priority Review for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) for the Treatment of Advanced Renal Cell Carcinoma

11.02.2019 | 23:55 Uhr | Ressort: Economy | Quelle: Presseportal


Darmstadt, Germany and New York (ots/PRNewswire) -

Not intended for US, Canada and UK-based media

Merck and Pfizer Inc. (NYSE: PFE) today announced that the US Food
and Drug Administration (FDA) has accepted for Priority Review the
supplemental Biologics License Application (sBLA) for BAVENCIO®
(avelumab) in combination with INLYTA® (axitinib)* for patients with
advanced renal cell carcinoma (RCC). The application has been given a
target action date in June 2019.

"The combination of BAVENCIO with INLYTA builds on Pfizer's
significant heritage in advancing standards of care for patients with
advanced RCC and has the potential to make a meaningful impact for
the lives of patients," said Chris Boshoff, M.D., Ph.D., Chief
Development Officer, Oncology, Pfizer Global Product Development. "We
look forward to working with the FDA to bring this potential new
treatment option to patients as quickly as possible."

"Our alliance is focused on the development of potential new
treatment options for patients with cancers that have high unmet
medical needs, including the broad spectrum of people living with
advanced RCC," said Luciano Rossetti, M.D., Executive Vice President,
Head of Global Research & Development at the Biopharma business of
Merck. "This regulatory milestone, which closely follows the
acceptance of our application in Japan, represents an important step
forward for science and for patients."

The submission is based on data from the pivotal Phase III JAVELIN
Renal 101 trial, which were presented in a Presidential Symposium at
the European Society of Medical Oncology (ESMO) 2018 Congress in
Munich. In December 2017, the FDA granted Breakthrough Therapy
Designation for BAVENCIO in combination with INLYTA for
treatment-naïve patients with advanced RCC.

Despite available therapies, the outlook for patients with
advanced RCC remains poor.[1] Approximately 20% to 30% of patients
are first diagnosed at the metastatic stage.[2] The five-year
survival rate for patients with metastatic RCC is approximately
12%.[1]

The clinical development program for avelumab, known as JAVELIN,
involves at least 30 clinical programs and more than 9,000 patients
evaluated across more than 15 different tumor types. In addition to
RCC, these tumor types include breast, gastric/gastro-esophageal
junction, and head and neck cancers, Merkel cell carcinoma, non-small
cell lung cancer, and urothelial carcinoma.

*The combination of BAVENCIO and INLYTA is under clinical
investigation for advanced RCC, and there is no guarantee this
combination will be approved for advanced RCC by any health authority
worldwide. In the US, INLYTA is approved as monotherapy for the
treatment of advanced RCC after failure of one prior systemic
therapy. INLYTA is also approved by the European Medicines Agency
(EMA) for use in the EU in adult patients with advanced RCC after
failure of prior treatment with SUTENT® (sunitinib) or a cytokine.

About Renal Cell Carcinoma

RCC is the most common form of kidney cancer, accounting for about
2% to 3% of all cancers in adults.[3],[4] The most common type of RCC
is clear cell carcinoma, accounting for approximately 70% of all
cases.[3] In 2019, an estimated 73,820 new cases of kidney cancer
will be diagnosed in the US.[5]

About BAVENCIO® (avelumab)

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1)
antibody. BAVENCIO has been shown in preclinical models to engage
both the adaptive and innate immune functions. By blocking the
interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to
release the suppression of the T cell-mediated antitumor immune
response in preclinical models.[6]-[8] BAVENCIO has also been shown
to induce NK cell-mediated direct tumor cell lysis via
antibody-dependent cell-mediated cytotoxicity (ADCC) in
vitro.[8]-[10] In November 2014, Merck and Pfizer announced a
strategic alliance to co-develop and co-commercialize BAVENCIO.

Approved Indications in the US

In the US, the FDA granted accelerated approval for BAVENCIO for
the treatment of (i) adults and pediatric patients 12 years and older
with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with
locally advanced or metastatic urothelial carcinoma (mUC) who have
disease progression during or following platinum-containing
chemotherapy, or have disease progression within 12 months of
neoadjuvant or adjuvant treatment with platinum-containing
chemotherapy. These indications are approved under accelerated
approval based on tumor response rate and duration of response.
Continued approval for these indications may be contingent upon
verification and description of clinical benefit in confirmatory
trials.

BAVENCIO is currently approved for patients with MCC in more than
45 countries globally, with the majority of these approvals in a
broad indication that is not limited to a specific line of treatment.

Important Safety Information from the US FDA Approved Label

The warnings and precautions for BAVENCIO include immune-mediated
adverse reactions (such as pneumonitis, hepatitis, colitis,
endocrinopathies, nephritis and renal dysfunction, and other adverse
reactions), infusion-related reactions and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in
patients treated with avelumab for mMCC and patients with locally
advanced or mUC include fatigue, musculoskeletal pain, diarrhea,
nausea, infusion-related reaction, peripheral edema, decreased
appetite/hypophagia, urinary tract infection and rash.

About INLYTA® (axitinib)

INLYTA is an oral therapy that is designed to inhibit tyrosine
kinases, including vascular endothelial growth factor (VEGF)
receptors 1, 2 and 3; these receptors can influence tumor growth,
vascular angiogenesis and progression of cancer (the spread of
tumors). In the US, INLYTA is approved for the treatment of advanced
renal cell carcinoma (RCC) after failure of one prior systemic
therapy. INLYTA is also approved by the European Medicines Agency
(EMA) for use in the EU in adult patients with advanced RCC after
failure of prior treatment with sunitinib or a cytokine.

INLYTA Important Safety Information from the US FDA Approved Label

In the study of advanced RCC after failure of one prior systemic
therapy, the warnings and precautions for INLYTA include
hypertension, including hypertensive crisis, arterial and venous
thrombotic events, hemorrhagic events, cardiac failure,
gastrointestinal perforation and fistula, hypothyroidism, wound
healing complications, reversible posterior leukoencephalopathy
syndrome (RPLS), proteinuria, liver enzyme elevation, hepatic
impairment, and fetal harm during pregnancy.

Common adverse events (reported in at least 20% of patients) in
patients receiving INLYTA were diarrhea, hypertension, fatigue,
decreased appetite, nausea, dysphonia, hand-foot syndrome, weight
decreased, vomiting, asthenia, and constipation.

For more information and full Prescribing Information, visit
www.INLYTA.com.

About SUTENT® (sunitinib malate)

Sunitinib is a small molecule that inhibits multiple receptor
tyrosine kinases, some of which are implicated in tumor growth,
pathologic angiogenesis, and metastatic progression of cancer.
Sunitinib was evaluated for its inhibitory activity against a variety
of kinases (>80 kinases) and was identified as an inhibitor of
platelet-derived growth factor receptors (PDGFR? and PDGFR?),
vascular endothelial growth factor receptors (VEGFR1, VEGFR2 and
VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3
(FLT3), colony stimulating factor receptor Type 1 (CSF-1R), and the
glial cell-line derived neurotrophic factor receptor (RET).

SUTENT is indicated in the US for the treatment of
gastrointestinal stromal tumor (GIST) after disease progression on or
intolerance to imatinib mesylate; the treatment of advanced RCC; the
adjuvant treatment of adult patients at high risk of recurrent RCC
following nephrectomy; and the treatment of progressive,
well-differentiated pancreatic neuroendocrine tumors (pNET) in
patients with unresectable locally advanced or metastatic disease.

SUTENT Important Safety Information from the US FDA Approved Label

Boxed Warning/Hepatotoxicity has been observed in clinical trials
and postmarketing experience. Hepatotoxicity may be severe, and in
some cases fatal. Monitor hepatic function and interrupt, reduce, or
discontinue dosing as recommended. Fatal liver failure has been
observed. Monitor liver function tests before initiation of
treatment, during each cycle of treatment, and as clinically
indicated. Interrupt SUTENT for Grade 3 or 4 drug-related hepatic
adverse reactions and discontinue if there is no resolution. Do not
restart SUTENT if patients subsequently experience severe changes in
liver function tests or have signs and symptoms of liver failure.

Additional warnings and precautions for SUTENT include
cardiovascular events, QT prolongation and Torsades de Pointes,
hypertension, hemorrhagic events, tumor lysis syndrome (TLS),
thrombotic microangiopathy (TMA), proteinuria, dermatologic
toxicities including erythema multiforme, Sevens-Johnson syndrome,
and toxic epidermal necrolysis, necrotizing fasciitis, thyroid
dysfunction, hypoglycemia, osteonecrosis of the jaw (ONJ), impaired
wound healing, embryo fetal toxicity and impaired reproductive
potential, potential harm during lactation, venous thromboembolic
events, reversible posterior leukoencephalopathy syndrome (RPLS), and
pancreatic function.

Common adverse reactions (reported in at least 20% of patients) in
patients receiving SUTENT for treatment-naïve metastatic RCC were
diarrhea, fatigue, nausea, anorexia, altered taste,
mucositis/stomatitis, pain in extremity/limb discomfort, vomiting,
bleeding, all sites, hypertension, dyspepsia, arthralgia, abdominal
pain, rash, hand-foot syndrome, back pain, cough, asthenia, dyspnea,
skin discoloration/yellow skin, peripheral edema, headache,
constipation, dry skin, fever, and hair color changes.

Common adverse reactions (reported in at least 20% of patients) in
patients receiving SUTENT for adjuvant treatment of RCC, GIST or pNET
- and more commonly than in patients given placebo - were
mucositis/stomatitis/oral syndromes, diarrhea, fatigue, asthenia,
hand-foot syndrome, hypertension, altered taste, nausea, dyspepsia,
abdominal pain, hypothyroidism/TSH increased, rash, hair color
changes, anorexia, skin discoloration, constipation, vomiting,
bleeding events, epistaxis, and dysgeusia.

For more information and full Prescribing Information, visit
www.SUTENT.com.

About Merck-Pfizer Alliance

Immuno-oncology is a top priority for Merck and Pfizer. The global
strategic alliance between Merck and Pfizer enables the companies to
benefit from each other's strengths and capabilities and further
explore the therapeutic potential of avelumab, an anti-PD-L1 antibody
initially discovered and developed by Merck. The immuno-oncology
alliance is jointly developing and commercializing avelumab and
advancing Pfizer's PD-1 antibody. The alliance is focused on
developing high-priority international clinical programs to
investigate avelumab as a monotherapy as well as combination
regimens, and is striving to find new ways to treat cancer.

All Merck Press Releases are distributed by e-mail at the same
time they become available on the Merck Website. Please go to
www.merckgroup.com/subscribe to register online, change your
selection or discontinue this service.

About Merck

Merck, a leading science and technology company, operates across
healthcare, life science and performance materials. Around 51,000
employees work to make a positive difference to millions of people's
lives every day by creating more joyful and sustainable ways to live.
From advancing gene editing technologies and discovering unique ways
to treat the most challenging diseases to enabling the intelligence
of devices - the company is everywhere. In 2017, Merck generated
sales of EUR 15.3 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been
key to Merck's technological and scientific advances. This is how
Merck has thrived since its founding in 1668. The founding family
remains the majority owner of the publicly listed company. Merck
holds the global rights to the Merck name and brand. The only
exceptions are the United States and Canada, where the business
sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma
in life science, and EMD Performance Materials.

Pfizer Inc.: Working together for a healthier world®

At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value in
the discovery, development and manufacture of health care products.
Our global portfolio includes medicines and vaccines as well as many
of the world's best-known consumer health care products. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge the
most feared diseases of our time. Consistent with our responsibility
as one of the world's premier innovative biopharmaceutical companies,
we collaborate with health care providers, governments and local
communities to support and expand access to reliable, affordable
health care around the world. For more than 150 years, we have worked
to make a difference for all who rely on us. We routinely post
information that may be important to investors on our website at
www.pfizer.com. In addition, to learn more, please visit us on
www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News,
LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice

The information contained in this release is as of February 11,
2019. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new information
or future events or developments.

This release contains forward-looking information about BAVENCIO
(avelumab), including a potential new indication for BAVENCIO in
combination with INLYTA (axitinib) for the treatment of patients with
advanced renal cell carcinoma, the alliance between Merck and Pfizer
involving BAVENCIO and clinical development plans, including their
potential benefits, that involves substantial risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied by such statements. Risks and uncertainties
include, among other things, uncertainties regarding the commercial
success of BAVENCIO; the uncertainties inherent in research and
development, including the ability to meet anticipated clinical
endpoints, commencement and/or completion dates for our clinical
trials, regulatory submission dates, regulatory approval dates and/or
launch dates, as well as the possibility of unfavorable further
analyses of existing clinical data and uncertainties regarding
whether the other primary endpoint of JAVELIN Renal 101 will be met;
risks associated with interim data; the risk that clinical trial data
are subject to differing interpretations and assessments by
regulatory authorities; whether regulatory authorities will be
satisfied with the design of and results from our clinical studies;
whether and when any drug applications may be filed for BAVENCIO in
combination with INLYTA for the potential new indication in any other
jurisdictions or in any jurisdictions for any other potential
indications for BAVENCIO or combination therapies; whether and when
the pending applications in the U.S. and Japan for BAVENCIO in
combination with INLYTA for the potential new indication may be
approved and whether and when regulatory authorities in any
jurisdictions where any other applications are pending or may be
submitted for BAVENCIO or combination therapies may approve any such
applications, which will depend on myriad factors, including making a
determination as to whether the product's benefits outweigh its known
risks and determination of the product's efficacy, and, if approved,
whether they will be commercially successful; decisions by regulatory
authorities impacting labeling, manufacturing processes and/or other
matters that could affect the availability or commercial potential of
BAVENCIO or combination therapies, including BAVENCIO in combination
with INLYTA for the potential new indication; and competitive
developments.

A further description of risks and uncertainties can be found in
Pfizer's Annual Report on Form 10-K for the fiscal year ended
December 31, 2017, and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned "Risk Factors" and
"Forward-Looking Information and Factors That May Affect Future
Results", as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission and
available at www.sec.gov and www.pfizer.com.

References

1. National Cancer Institute: SEER Stat Fact Sheets: Kidney and
renal pelvis. Available from:
http://seer.cancer.gov/statfacts/html/kidrp.html. Accessed
February 2019.
2. Ljungberg B, Campbell S and Cho H. The Epidemiology of Renal Cell
Carcinoma. Eur Urol. 2011;60:615-621.
3. American Cancer Society. What is kidney cancer? Available from:
https://www.cancer.org/cancer/kidney-cancer/about.html. Accessed
February 2019.
4. Escudier B, Porta C, Schmidinger M et al Renal cell carcinoma:
ESMO clinical practice guidelines for diagnosis, treatment and
follow-up. Annal Oncol. 2014; 25(Suppl3):iii49-iii56.
5. American Cancer Society. Cancer facts and figures 2019. Available
at: https://www.cancer.org/content/dam/cancer-org/research/cancer
-facts-and-statistics/annual-cancer-facts-and-figures/2019/cancer
-facts-and-figures-2019.pdf. Accessed February 2019
6. Dolan DE, Gupta S. PD-1 pathway inhibitors: changing the
landscape of cancer immunotherapy. Cancer Control.
2014;21(3):231-237.
7. Dahan R, Sega E, Engelhardt J, Selby M, Korman AJ, Ravetch JV.
Fc?Rs modulate the anti-tumor activity of antibodies targeting
the PD-1/PD-L1 axis. Cancer Cell. 2015;28(3):285-295.
8. Boyerinas B, Jochems C, Fantini M, et al. Antibody-dependent
cellular cytotoxicity activity of a novel anti-PD-L1 antibody
avelumab (MSB0010718C) on human tumor cells. Cancer Immunol Res.
2015;3(10):1148-1157.
9. Kohrt HE, Houot R, Marabelle A, et al. Combination strategies to
enhance antitumor ADCC. Immunotherapy. 2012;4(5):511-527.
10. Hamilton G, Rath B. Avelumab: combining immune checkpoint
inhibition and antibody-dependent cytotoxicity. Expert Opin Biol
Ther. 2017;17(4):515-523.

Merck:

Media Relations:

+49-151-1454-6328

friederike.segeberg@merckgroup.com

Investor Relations:

+49-6151-72-3321

investor.relations@merckgroup.com

Pfizer:

Media Relations:

+1-212-733-6213

jessica.m.smith@pfizer.com

Investor Relations:

+1-212-733-8160

ryan.crowe@pfizer.com



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ots Originaltext: Merck KGaA
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