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Lahir di salah satu desa di kota terkecil "Pati" (menurut kepala sekolah waktu SD) pada tahun 1967, maklum karena waktu itu ditemapat saya belum musimnya menggunakan akte kelahiran untuk bukti pencantuman tanggal lahir siswa diijazah, sehingga tanggal lahir sesuai belas kasihan kepala sekolah yang mengeluarkan ijazah SD saya. Sekolah di SMPN1 Winong, sekolah unggulan di kota kecamatan Winong waktu itu. Setelah lulus SMP melanjutkan di SMA1 N Pati, juga salah satu sekolah SMA terfaforit di kota Pati. Akhirnya kuliahnya tersangkut UMPTN di Farmasi UGM, kesasar di KIMIA Mipa UGM dua tahun dan berakhir di Fakultas Kedokteran UGM. Sudah berkeluarga, dengan enam keturunan, hanya saja salah satunya sudah diminta kembali oleh Sang Maha Kuasa, bair jadi tabungan kami kelak, semoga. Istri juga seorang dokter, yang sangat rajin ngoyak-ngoyak anak-anak untuk belajar sambil praktek di rumah. Baik saya maupun istri, pernah kerja di di beberapa RS tetapi kemudian kami berdua meneguhkan diri di lembaga pendidikan untuk mengabdikan ilmu di pendidikan. Semoga bermanfaat.

Kalydeco, obat baru untuk penderita cystic fibrosis

Meskipun penyakit yang satu ini cukup jarang kejadiaannya di masyarakat, tetapi sangat berbahaya.Kelainan genetik yang menyebabkan kerusakan dan gangguan fungsi paru, pankreas dan berbagai organ vital lainnya, biasanya akan berakhir dengan kematian.Direleasenya obat baru ini oleh FDA tentu memberikan harapan besar bagi masa depan penderita cystic fibrosis. Selama ini memang sudah ada terapi obat untuk kelainan ini tetapi belum juga definitf dan hasilnya belum memuaskan. Selamat semoga bermanfaat. Berita selengkapnya silakan baca pada lintasan berita berikut:FDA approves Kalydeco to treat rare form of cystic fibrosis
Breakthrough therapy targets defective protein

The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.

CF is a serious genetic disorder affecting the lungs and other organs that ultimately leads to an early death. It is caused by mutations (defects) in a gene that encodes for a protein called CFTR that regulates ion (such as chloride) and water transport in the body. The defect in chloride and water transport results in the formation of thick mucus that builds up in the lungs, digestive tract and other parts of the body leading to severe respiratory and digestive problems, as well as other complications such as infections and diabetes.

CF, which affects about 30,000 people in the United States, is the most common fatal genetic disease in the Caucasian population. About 4 percent of those with CF, or roughly 1,200 people, are believed to have the G551D mutation.

“Kalydeco is an excellent example of the promise of personalized medicine – targeted drugs that treat patients with a specific genetic makeup,” said FDA Commissioner Margaret A. Hamburg, M.D. “The unique and mutually beneficial partnership that led to the approval of Kalydeco serves as a great model for what companies and patient groups can achieve if they collaborate on drug development.”

The FDA reviewed and approved Kalydeco in approximately three months under the agency’s priority review program that is designed to expedite the review of drugs. The priority review program uses a six-month review, instead of the standard 10 months, for drugs that may offer significant advances in treatment over available therapy.

Kalydeco was approved ahead of the drug’s April 18, 2012 prescription user fee goal date and is designated as an orphan drug, which identifies the disease as affecting fewer than 200,000 people in the United States.

In patients with the G551D mutation, Kalydeco, a pill taken two times a day with fat-containing food, helps the protein made by the CFTR gene function better and as a result, improves lung function and other aspects of CF such as increasing weight gain.

“Kalydeco is the first available treatment that targets the defective CFTR protein, which is the underlying cause of cystic fibrosis,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This is a breakthrough therapy for the cystic fibrosis community because current therapies only treat the symptoms of this genetic disease.”

Two 48-week, placebo-controlled clinical studies involving 213 patients, one in patients ages 12 years and older and another in patients ages 6 years to 11 years, were used to evaluate the safety and efficacy of Kalydeco in CF patients with the G551D mutation. In both studies, treatment with Kalydeco resulted in significant and sustained improvement in lung function.

Kalydeco is effective only in patients with CF who have the G551D mutation. It is not effective in CF patients with two copies of the F508 mutation in the CFTR gene, which is the most common mutation that results in CF. If a patient’s mutation status is not known, an FDA-cleared CF mutation test should be used to determine whether the G551D mutation is present.

The most common side effects of Kalydeco include upper respiratory tract infection, headache, stomach ache, rash, diarrhea, and dizziness.

Kalydeco is manufactured by Vertex Pharmaceuticals Inc. of Cambridge, Mass.

FDA merelease obat baru lagi, Vismodegib, obat ca sel basalis metastasis

Vismodegib merupakan obat untuk karsinoma sel basal metastasis atau kanker kulit sel basal fase lanjut yang tidak memungkinkan untu pembedahan atau kekambuhan pasca terapi pembedahan.

Prinsip kerja dari kerja obat baru ini adalah mempengaruhi signaling pada bagian subseluler yang disebut sistem signaling “hedgehog pathway”. Sebagaimana tampak pada gambar

hedgehog pathway

Berita lengkap tentang obat baru ini silakan baca pada paparan berikut:

On January 30, 2012, the U. S. Food and Drug Administration approved vismodegib (ERIVEDGE Capsule, Genentech, Inc.) for the treatment of adults with metastatic basal cell carcinoma or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.

obat kanker sel basalis

vismodegip

Efficacy was demonstrated in a single-arm, parallel cohort trial enrolling 104 patients. Patients received 150 mg of vismodegib daily. Central pathologic review of archival or baseline tissue confirmed the diagnosis of basal cell carcinoma (BCC) in 96 patients: 33 patients with metastatic basal cell carcinoma (mBCC) and 63 patients with locally advanced basal cell carcinoma (laBCC).

Efficacy was evaluated in these 96 patients with confirmed BCC. The median age of this population was 62 years, 61% were male, and 97% had an ECOG performance status of 0 or 1. Twenty‑one percent of patients carried a diagnosis of Gorlin syndrome. Sixty-six percent had locally advanced disease; 34% had metastatic disease. Among those with mBCC, 97% were previously treated. Prior therapy included surgery (97%), radiotherapy (58%), and systemic therapies (30%). Among laBCC patients, 94% were previously treated. Prior therapies included surgery (89%), radiotherapy (27%), and systemic/topical therapies (11%).

The trial’s primary endpoint was objective response rate (ORR) assessed by an independent review facility. Tumor response criteria for laBCC included assessment of tumor size, the presence or absence of ulceration, and biopsy of local disease sites. The criteria for complete response in localized disease required tumor biopsy (ies) demonstrating no pathologic evidence of BCC. RECIST version 1.0 criteria were used to assess responses in the mBCC population.

The ORRs were 30.3% (95% CI: 15.6, 48.2) and 42.9% (95% CI: 30.5, 56.0) in patients with mBCC and laBCC, respectively. All responses in the mBCC cohort were partial responses. For the 63 evaluable patients with laBCC, 13 (20.6%) patients had complete responses and 14 (22.2%) had partial responses. The median response duration was 7.6 months (95% CI: 5.6, not estimable) and 7.6 months (95% CI: 5.6, 9.7) for patients with mBCC and laBCC, respectively.

Safety was evaluated in 138 patients who received vismodegib as monotherapy for laBCC or mBCC. Adverse reactions occurring in more than 10% of patients were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia. In clinical trials, a total of 3 of 10 pre-menopausal women developed amenorrhea. Grade 3 adverse reactions occurring in more than 1% of patients were weight loss, fatigue, muscle spasms, and decreased appetite.

Healthcare professionals should verify pregnancy status prior to the initiation of vismodegib, counsel pregnant women on the potential risks to the embryo/fetus, and advise non-pregnant women to use highly effective contraception during treatment with vismodegib and for up to 7 months after the last dose. To avoid exposing an embryo/fetus to vismodegib that may be contained in semen, male patients should use condoms with spermicide during treatment with vismodegib, and for 2 months after the last dose. Healthcare providers should report to Genentech any cases of exposure during pregnancy (either direct exposure in female patients or through seminal fluid from male patients), and should encourage pregnant women to participate in the Erivedge pregnancy pharmacogvigilance program to collect information on pregnancy outcomes.

Vismodegib inhibits the Hedgehog pathway, an important embryonic developmental pathway. Reproductive toxicology studies in rats demonstrated that vismodegib exposure during organogensis results in embryo-fetal death at higher exposures and severe birth defects at exposures within the range achieved with the recommended human dose.

The recommended dose and schedule for vismodegib is 150 mg orally daily. Vismodegib may be taken with or without food.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203388lbl.pdf[download id=”1″]

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

apakah bevacizumab itu? avastin adalah contoh produk paten bevacizumab

Avastin is a cancer medicine that interferes with the growth of cancer cells by blocking the formation and growth of new blood vessels in the tumor which slows their growth.

obat biologis anti ca mamae

Avastin is used to treat a certain type of brain tumor as well as cancers of the kidney, colon, rectum, lung, or breast. It is usually given as part of a combination of cancer medicines.

Avastin may also be used for purposes other than those listed here.

Most important: Avoid having surgery while you are being treated with Avastin. You may have problems with wound healing, which could result in bleeding or infection.

monoklonal antibodi anti VEGF

obat biologis

If you need to have any type of surgery, you will need to stop receiving Avastin for at least 4 weeks while your surgical incision heals.

Before being treated with Avastin, tell your doctor if you have liver disease, kidney disease, heart disease, high blood pressure, a history of stroke or blood clots, or an open wound.

Some people receiving a Avastin injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, chills, wheezing, or chest pain during the injection.

Call your doctor at once if you have serious side effects such as blood in your stools or vomit, sudden numbness or weakness (especially on one side of the body), sudden headache or confusion, problems with vision or speech, chest pain spreading to the arm or shoulder, shortness of breath, swelling, rapid weight gain, or flu symptoms.

Avastin can cause a rare but serious neurologic disorder affecting the brain. Symptoms include headache, confusion, vision problems, feeling light-headed, fainting, and seizure (blackout or convulsions). These rare symptoms may occur within hours of your first dose of Avastin, or they may not appear for up to a year after your treatment started. Call your doctor at once if you have any of these side effects.

To be sure Avastin is not causing harmful effects, your blood pressure will need to be tested on a regular basis. Your urine may also need to be tested. Do not miss any scheduled visits to your doctor.

 

 

 

 

 

 

 

struktur antibodi

Avastin can affect a woman’s fertility (ability to have children). Talk to your doctor about your specific risks.

Kabar gembira, Terapi ajuvan Bevacizumab dapat menghambat perkembangan HER2-Negative Breast Cancer

Bevacizumab adalah antibodi monoklonal anti VEGF A (vascular endothelial growt factor A) yang sudah terbukti efektif untuk penderita ca mamae her-2 negatif metastasis. Dari hasil penelitian klinis terbaru yang dilaporkan oleh NEJM dengan judul “Neoadjuvant Chemotherapy and Bevacizumab for HER2-Negative Breast Cancer” membuktikan bahwa obat biologis ini juga efektif sebagai terapi ajuvan pada penderita ca mamae her-2 negatif fase awal yang diterapi dengan epirubisin, ciklofosfamid yang diikuti docetaxel. Harapan baru bagi penderita ca mamae fase awal yang selama ini belum bisa banyak berharap dengan sdiaan terapi yang sudah ada. Semoga hasil penelitian baru ini memberikan banyak manfaat pada masyarakat di Indonesia. Berminat membaca laporan lengkapnya? Silakan buka www. nejm.com.

Bagaimana penggunaan Neoajuvan Bevacizumab funtuk penderita breast ca dengan HER2-Negative

Bevacizumab adalah monoklonal antibodi anti vascular endotelial growt factor A (VEGF). Dari uji klinik sebelumnya terbukti bahwa bevacizumab efektif untuk penderita ca mamae her-2 negatif metastasis (stadium lanjut). Bagaimana kemanjuran penambahan bevacizumab untuk penderita ca mamae stadium awal yang diterapi epirubicin dan cyclophosphamide yang dilanjutkan dengan docetaxel belum diketahui. Laporan dari NEJM yang berjudul “Neoadjuvant Chemotherapy and Bevacizumab for HER2-Negative Breast Cancer

Jangan digunakan obat yang sudah kedaluwarsa, habis masa edar

kewapadaan

kewapadaan dini terhadap obat

Don’t Be Tempted to Use Expired Medicines
By Sherunda Lister, Office of Communications

Woman reading prescription label

With curdled milk or petrified cucumbers it’s not hard to know when your food is past its prime, but how do you know when your medicine is past its prime?

Using expired medical products is risky and possibly harmful to your health. In the late 1970s, the U.S. Food and Drug Administration (FDA) began requiring an expiration date on prescription and over-the counter medicines. “Expiration dates on medical products are a critical part of determining if the product is safe to use and will work as intended,” says FDA pharmacist, Ilisa Bernstein. Sometimes following “EXP,” the expiration date can be found printed on the label or stamped onto the bottle or carton; it is important to know and adhere to the expiration date on your medicine.

Expired medical products can be less effective or risky due to a change in chemical composition or decrease in potency. Improper storage – such as a humid bathroom cabinet – can also contribute to decreased effectiveness in medicines that have not reached their posted expiration date. To help ensure the proper shelf life of your medicine, it is better to store medicine in a controlled climate.

If you have expired medicine, it should be disposed of properly. Read the label for disposal instructions that may be included.

If no instructions are provided, a drug take-back program, if available, is a good way to dispose of expired, unwanted or unused medicine. Check with your local government to see if there is a drug take-back program available in your area. If no take-back program is available, federal guidelines recommend throwing medicine away in the household trash by placing it in a bag or container and mixing with coffee grounds or kitty litter.

However, some medicine is specifically recommended for flushing down a toilet or sink because while safe and effective when used as prescribed, it could be especially harmful to a child, pet, or anyone else if taken accidentally. For a list of medicines recommended for disposal by flushing, as well as other information on proper disposal, please see the Disposal of Unused Medicines page.

“Once the expiration date has passed there is no guarantee that an expired medicine will be safe and effective,” says Bernstein. “If your medicine has expired, do not use it.”

info obat baru, obat antikanker ginjal diberikan ijin edar oleh FDA

FDA NEWS RELEASE

For Immediate Release: Jan. 27, 2012
Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Inlyta to treat patients with a type of advanced kidney cancer
Drug helps keep cancer from progressing

The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.

Renal cell carcinoma is a type of kidney cancer that starts in the lining of very small tubes in the kidney. Inlyta works by blocking certain proteins called kinases that play a role in tumor growth and cancer progression. Inlyta is a pill that patients take twice a day.

“This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Collectively, this unprecedented level of drug development within this time period has significantly altered the treatment paradigm of metastatic kidney cancer, and offers patients multiple treatment options.”

Recently approved drugs for the treatment of kidney cancer include sorafenib (2005), sunitinib (2006), temsirolimus (2007), everolimus (2009), bevacizumab (2009) and pazopanib (2009).

The safety and effectiveness of Inlyta were evaluated in a single randomized, open-label, multi-center clinical study of 723 patients whose disease had progressed on or after treatment with one prior systemic therapy. The study was designed to measure progression-free survival, the time a patient lived without the cancer progressing. Results showed a median progression-free survival of 6.7 months compared to 4.7 months with a standard treatment (sorafenib).

The most common side effects observed in greater than 20 percent of patients in the clinical study were diarrhea, high blood pressure (hypertension), fatigue, decreased appetite, nausea, loss of voice (dysphonia), hand-foot syndrome (palmar-plantar erythrodysesthesia), weight loss, vomiting, weakness (asthenia) and constipation.

Patients with high blood pressure should have it well-controlled before taking Inlyta. Some patients who took Inlyta experienced bleeding problems, which in some cases were fatal. Patients with untreated brain tumors or gastrointestinal bleeding should not take Inlyta.

Inlyta is marketed by New York City-based Pfizer Inc.

For more information:

FDA: Office of Hematology and Oncology Products

FDA: Approved Drugs: Questions and Answers

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SUATU RENUNGAN DARI TETANGGA SEBELAH

Berikut kami kopikan editorial dari NEJM minggu ini. Semoga bermanfaat.
Fighting Fire with Fire: Rekindling the Bevacizumab Debate

Alberto J. Montero, M.D., and Charles Vogel, M.D.

N Engl J Med 2012; 366:374-375January 26, 2012

Article
References

The results of the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-40 trial1 and the GeparQuinto (GBG44) trial,2 both of which are reported in this issue of the Journal, are particularly timely given the definitive announcement by the Food and Drug Administration (FDA) on November 18, 2011, revoking approval of bevacizumab in combination with paclitaxel for the treatment of metastatic breast cancer (see www.fda.gov/downloads/NewsEvents/Newsroom/UCM280546.pdf). Bevacizumab, a monoclonal antibody against circulating vascular endothelial growth factor A, was granted accelerated FDA approval in 2008 for the first-line treatment of human epidermal growth factor receptor 2 (HER2)–negative metastatic breast cancer. Initial approval was given on the basis of evidence showing a significant improvement in progression-free survival, but not overall survival, with weekly treatment with paclitaxel and bevacizumab, as compared with paclitaxel alone.3,4 This approval led to a large number of clinical trials of bevacizumab with other chemotherapeutic agents; the NSABP B-40 and GBG44 studies are among the first trials of neoadjuvant therapy to report preliminary data. Both trials were designed on the basis of the plausible assumption that a surrogate clinical end point, such as progression-free survival, should be used in cases of metastatic breast cancer, since patients live far longer than the duration of a trial and typically receive many other systemic therapies that can confound the end point of overall survival.5 The unresolved issue is whether significant improvements in a surrogate end point like progression-free survival, in the absence of a benefit for overall survival, are potentially predictive of curative benefits in patients with earlier-stage breast cancer. Only data on recurrence and survival from ongoing trials of adjuvant and neoadjuvant therapy with bevacizumab can definitively resolve this issue.

The ongoing controversy surrounding bevacizumab therapy for breast cancer goes beyond the science of tumor angiogenesis and involves broader questions about the use of surrogate end points in clinical trials, as well as economic arguments over the ever-increasing cost of new medicines for the treatment of cancer.5,6 It is through this lens that the NSABP B-40 and GBG44 trials should be viewed, since each of these trials reports a significant improvement with bevacizumab in another putative surrogate clinical end point: pathological complete response. The primary objective of both the GBG44 and NSABP B-40 trials was to determine whether combining bevacizumab with various chemotherapy regimens would significantly improve the rate of pathological complete response in women with nonmetastatic HER2-negative breast cancer. Both studies showed significant improvements in the rate of pathological complete response. The two studies used different definitions of the primary end point; in the GBG44 trial, pathological complete response was defined as the absence of residual tumor in the breast and nodes, whereas in the NSABP B-40 trial, the less stringent definition of the absence of residual tumor in the breast only was used. In the GBG44 study, the overall rate of pathological complete response with the addition of bevacizumab was 3.5 percentage points higher than the rate without bevacizumab (P=0.04), whereas in the NSABP B-40 study, the rate with bevacizumab was 6.3 percentage points higher than the rate without bevacizumab (P=0.02). However, when the more stringent definition of pathological complete response was used, the differences noted in the NSABP B-40 were no longer significant. An analysis of survival is still premature in both trials.

The GBG44 and NSABP B-40 trials used docetaxel-based chemotherapy regimens, rather than the weekly paclitaxel regimen that was used in the trial that led to the initial approval of bevacizumab.4 The weekly paclitaxel–bevacizumab regimen has led to a median progression-free survival of approximately 1 year in three separate trials,4,7,8 which is arguably better than the progression-free survival that has been reported with all other bevacizumab-based chemotherapy regimens in patients with metastatic breast cancer. One possible explanation that has been posited for this discrepancy is that the benefit of bevacizumab is chemotherapy-specific, and when it is combined with weekly paclitaxel, it has a more synergistic antiangiogenic effect than when it is combined with other chemotherapies.9

Subgroup analyses in the NSABP B-40 and GBG44 trials revealed contradictory results. In the GBG44 trial, the rates of pathological complete response were significantly increased with bevacizumab therapy in patients with hormone-receptor–negative (“triple negative”) breast cancer, whereas in the NSABP B-40 trial, there was only a trend favoring bevacizumab in that population. In contrast, the NSABP B-40 trial showed a significant increase in the rate of pathological complete response in patients with hormone-receptor–positive cancer, whereas in the GBG44 trial, no differences were noted in that population. Some potential explanations for these discrepancies are well summarized in one of the articles2 and are likely to be due to differences between the two trials in eligibility criteria and study design. Although the benefits (in the case of the GBG44 trial) and trends (in the NSABP B-40 trial) with respect to triple-negative breast cancer are consistent with those in other trials,10 the specific benefit of bevacizumab in patients with hormone-receptor–positive cancer is unexpected and should be considered as hypothesis-generating. The cooperative groups from both trials are analyzing several biomarkers, and it is hoped that these analyses will elucidate robust predictive biomarkers for response to bevacizumab, which would increase the overall clinical benefit of this drug for patients with breast cancer by allowing more refined patient selection.

These two well-performed trials do not resolve existing controversies surrounding bevacizumab therapy. If surrogate end points like progression-free survival in patients with metastatic breast cancer and pathological complete response in the neoadjuvant setting are ultimately predictive of survival benefits in earlier-stage disease, then the use of these surrogates in clinical research will be vindicated, and the FDA’s decision to withdraw the indication of bevacizumab for metastatic breast cancer will be further called into question. However, in the context of unsustainable expenditures for cancer care in the United States,6 any survival benefit of bevacizumab, or other molecularly targeted drugs, will be balanced against the considerable development costs of modern molecularly targeted oncology drugs.

AXITINIB, ANTI CARCINOMA GINJAL YANG KEBAL DENGAN TERAPI SISTEMIK LAINNYA

Axitinib

Pada 27/1/2012 FDA telah memberikan ijin edar obat baru untuk kanker ginjal lanjut yang sudah kebal dengan terapi sistemik lainnya. Tentu ini suatu kabar gembira bagi penderita kanker ginjal lanjut yang sudah hampir putus harapan. Kata Allah, setiap penyakit ada obatnya. Masalahnya kita tahu tidak obat tersebut?
Berita selengkapnya tentang axitinib silakan dibaca pada artikel berikut.
Masih ada harapan On January 27, 2012, the U. S. Food and Drug Administration approved axitinib tablets (Inlyta, Pfizer, Inc.) for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy.

The approval is based on an international, randomized, open-label trial in patients with advanced renal cell carcinoma after failure of one prior systemic regimen. The primary efficacy endpoint was progression-free survival (PFS).

The trial enrolled 723 patients: 361 patients were assigned to receive axitinib 5 mg orally twice daily, and 362 patients were assigned to receive sorafenib 400 mg orally twice daily. Treatment continued until disease progression, unacceptable toxicity, and/or consent withdrawal. All enrolled patients had an ECOG performance status of 0 or 1 and all patients had received one prior systemic therapy that contained one of the following treatments: sunitinib, temsirolimus, bevacizumab or cytokine(s). The trial excluded patients who had uncontrolled hypertension.

The PFS analysis demonstrated a statistically significant improvement in PFS in patients receiving axitinib compared to patients receiving sorafenib (HR=0.67; 95% CI: 0.54, 0.81; p< 0.0001, log-rank test). The median PFS of patients receiving axitinib was 6.7 months (95% CI: 6.3, 8.6) compared to a median PFS of 4.7 months (95% CI: 4.6, 5.6) for patients receiving sorafenib. This improvement in PFS was greater in the cytokine-pretreated subgroup compared to the sunitinib-pretreated subgroup.

The most common (≥20%) adverse reactions in patients treated with axitinib were diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, palmar-plantar erythrodysesthesia (hand-foot) syndrome, weight decreased, vomiting, asthenia, and constipation. Other severe adverse reactions reported in axitinib-treated patients included hypertensive crisis, arterial and venous thrombotic events, hemorrhage, gastrointestinal perforation and fistula formation, and reversible posterior leukoencephalopathy syndrome.

The recommended dose schedule of axitinib is 5 mg orally twice daily, administered approximately 12 hours apart with or without a meal.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202324lbl.pdf

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

Indonesia negara tertinggi korban meninggal akibat flu burung, ayo siapa peduli?

“Sudah jatuh ketimpa tangga”, itulah pepatah yang ssuai untuk para peternak dan buruh ternak di Indonesia. Bagaimana tidak? Kehidupan keseharian mereka yang susah, dimana agar dapat menyambung hidup mereka harus memelihara ternak atau merawat ternak para juragan, tetapi kalau ada wabah flu burung mereka menjadi sasaran. Nasib malang kadang tidak bisa dibendung. Sungguh ironis negeri ini, wabah flu burung yang sudah terjadi sejak tahun 2005an sampai saat ini belum kelar juga cara pencegahan dan pengatasannya, padahal sudah berapa ratus milyar bahkan berapa trilyun dana yang sudah digelontorkan oleh pemerintah, baik pinjaman maupun uang sendiri, untuk penanganan satu masalah ini? tetapi korban-korban dari masyarakat golongan susah dan menderita sampai hari ini bahkan mungkin masa-masa mendatang masih tetap akan berjatuhan. Siapakah yang salah?
Mencari kambing hitam merupakan pekerjaan paling mudah dalam membicarakan permasalahan masyarakat, tetapi tidak untuk menyelesaikannya. Kepedulian bersama oleh seluruh elemen masyarakat merupakan tuntutan bagi penyelesaian masalah ini. Kenapa?
Ketahuilah! apabila masalah flu burung ini tidak segera teratasi, virus antiflu burung tidak segera tersedia, pencegahan dini tidak segera dilakukan, kampanye pencegahan dan edukasi pengenalan gejala dini tidak dilakukan dan rumah sakit-rumah sakit tidak disiapkan sejak dari sekarang maka korban yang berjatuhan bukan saja dari mereka yang berinteraksi dengan para unggas tetapi juga mereka para pemakai dasi yang tidak pernah bau kandang ayampun bisa jadi korban. Apakah demikian parah? Tunggu bukti? tentu kita semua tidak berharap demikian, ayo segera peduli!

Renungan akhir pekan
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