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FDA setujui terobosan obat baru , Ibrance , bagi penderita kanker payudara stadium lanjut yang positif estrogen - reseptor

FDA telah menyetujui Ibrance ( palbociclib ) , yang mewakili sebuah metode pengobatan baru untuk menangkap pertumbuhan tumor pada pasien kanker payudara stadium lanjut tertentu . IBRANCE menargetkan keluarga utama dari protein yang bertanggung jawab untuk pertumbuhan sel . Hasil penelitian tahap 2 menemukan kombinasi IBRANCE dan letrozole meningkatkan progression-free survival  10 bulan dibandingkan dengan letrozole saja . Lebih dari 80 persen pasien ER + kanker payudara metastatik menerima beberapa manfaat dari perawatan ini ....read more

FDA approves
groundbreaking new drug, Ibrance, for patients with estrogen-receptor positive
advanced breast cancer

Date:

February 3, 2015

Source:

University of
California, Los Angeles (UCLA), Health Sciences

Summary:

FDA has approved
Ibrance (palbociclib), representing a new treatment method to arrest tumor
growth in certain advanced breast cancer patients. IBRANCE targets a key family
of proteins responsible for cell growth. Results of a phase 2 study found the
combination of IBRANCE and letrozole improved progression-free survival by 10
months as compared to letrozole alone. Over 80 percent of metastatic ER+ breast
cancer patients received some benefit from this treatment.

..................

the U.S. Food and Drug
Administration today approved a potentially groundbreaking new drug to treat
women with advanced breast cancer, signaling a new treatment strategy to arrest
tumor growth and extend the time before the cancer worsens.

The drug, IBRANCE (palbociclib) was studied in 165 post-menopausal breast
cancer patients with advanced ER+, HER2- disease who had received no prior
systemic therapy for their metastatic disease. Early results from a clinical
study led by UCLA researchers showed a dramatic improvement and the FDA granted
the drug "breakthrough therapy" status in April 2013, allowing it to
be fast-tracked to early approval.

The ER+/HER2- subgroup represents the largest proportion of breast cancer
cases and is traditionally treated with therapies, like tamoxifen or letrozole,
that target the hormone receptor pathway.

"Palbociclib (IBRANCE) is the first drug in its class to be approved
by the FDA," said Dr. Richard Finn, the study's principal investigator and
a researcher at UCLA's Jonsson Comprehensive Cancer Center. "All of us at
UCLA are very proud of the important role we played in bringing this new agent
to patients."

Developed by Pfizer Inc., IBRANCE (palbociclib) targets a key family of
proteins (CDK4/6) responsible for cell growth by preventing cells from
dividing. Results of the multi-year phase 2 study showed a significant increase
in progression-free survival (PFS) for patients with advanced breast cancer
that was estrogen receptor positive (ER+), HER2-negative (HER2-), who were
given a combination of a standard anti-estrogen treatment, letrozole, and
palbociclib compared to letrozole alone.

"With the FDA approval, this study represents a potential
practice-changing result," said Dr. Dennis Slamon, director of the
Revlon/UCLA Women's Cancer Research Program and Clinical/Translational Research
at the Jonsson Cancer Center. "I believe palbociclib will now become a
standard treatment approach for postmenopausal women with ER+/HER2- metastatic
breast cancer."

Developing IBRANCE: A New Hope in the Fight Against Breast Cancer

The origin of the research began in 2007, when Finn and Slamon held a
pivotal meeting with Pfizer to discuss palbociclib and other experimental drugs
in its pipeline.

Preclinical work testing the drug in a panel of human breast cancer cells
growing in culture dishes showed very encouraging activity, specifically
against estrogen-receptor-positive (ER+) cancer cells. This led to a clinical
study collaboration with Pfizer led by Finn and Slamon built on laboratory work
directed at the Jonsson Cancer Center's Translational Oncology Research
Laboratory at UCLA.

Once the phase 1 study was completed and showed the drug was safe, the
phase 2 study was performed in 165 post-menopausal breast cancer patients with
advanced ER+, HER2- disease who had not received prior systemic therapy for
their metastatic disease.

Phase 2 results showed progression-free survival was essentially doubled to
20.2 months for patients who received palbociclib plus letrozole as compared to
10.2 months for those who received the current standard treatment of letrozole
alone. The PFS results indicated a 51 percent reduction in the risk of disease
progression with the addition of palbociclib to letrozole.

"What is really remarkable is that we doubled the median progression-free
survival," said Finn. "That type of result is not often seen in
cancer medicine."

Slamon added that, "the magnitude of the observed benefit was very
gratifying and reminiscent of results we saw when we conducted the initial
studies on Herceptin in HER2+ breast cancers two decades ago."

The results showed that over 80 percent of the metastatic ER+ breast cancer
patients in the study received some benefit from this treatment, said Finn and
Slamon. They also found the drug's safety profile is distinct from traditional
chemotherapy, but does result in a lowered white blood cell count, which was
manageable.

A phase 3 international clinical trial of the drug conducted by Finn and
Slamon with Pfizer in approximately 660 ER+, HER2- advanced breast cancer
patients has been completely enrolled.

Survivor Stories: A Second Chance at Life

When Janet Klein was first diagnosed with stage I ER+ breast cancer, she
decided to undergo a double mastectomy in 2004. A few years later, it was
discovered that the breast cancer had returned as metastatic disease in her
bones.

Klein's UCLA oncologist and Jonsson Cancer Center member Dr. Sara Hurvitz
told her about a phase 1 clinical trial that was being offered to UCLA patients
with advanced breast cancer in 2009.

Nine months after she enrolled in the trial and was prescribed IBRANCE
(palbociclib) in combination with an anti-estrogen treatment, her scans showed
no evidence of the cancer.

"I had a large party with a lot of champagne, it was life changing but
in a good way," said Klein.

The 59-year-old cancer survivor is celebrating again, after the FDA
approved the use of the drug.

"Sixty percent of all women diagnosed with this disease have my
variety, and this drug having this sort of an impact, so fast and so effectively,
is earth shattering," she said.

Gloria Zollar joined the phase 2 clinical trial in August 2010, after her
UCLA oncologist discovered that her advanced breast cancer had spread to her
bones. She has been on treatment since that time, over four years.

But only one year later, doctors noticed that her tumors had stopped
progressing, which allowed Zollar to remain active and continue playing golf.

"I am now in remission, and everyday I'm thankful to God that I'm
alive and able to see my great-grandchildren and spend time with them,"
said Zollar. The 78-year-old patient is excited that the drug is now available
to other women battling this deadly disease.

"I am very pleased that other women could have a second chance at life
like many of us who participated in the trial," she said.







Story Source:

The above story is based on materials provided by University
of California, Los Angeles (UCLA), Health Sciences. The original article was written by
Reggie Kumar.Note: Materials may be edited for content and length.

http://www.sciencedaily.com/releases/2015/02/150203190025.htm

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