Category Archives: Obat Baru

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!!!!! Ada vaksin antimalaria

NEJM telah melaporkan hasil uji klinik vaksin antimalaria. Berita selengkapnya sebagai berikut:
Original Article
A Field Trial to Assess a Blood-Stage Malaria Vaccine

Mahamadou A. Thera, M.D., M.P.H., Ogobara K. Doumbo, M.D., Ph.D., Drissa Coulibaly, M.D., Matthew B. Laurens, M.D., M.P.H., Amed Ouattara, Pharm.D., Abdoulaye K. Kone, M.D., Ando B. Guindo, M.D., Karim Traore, M.D., Idrissa Traore, M.D., Bourema Kouriba, Pharm.D., Ph.D., Dapa A. Diallo, M.D., Issa Diarra, Pharm.D., Modibo Daou, Pharm.D., Amagana Dolo, Pharm.D., Ph.D., Youssouf Tolo, Pharm.D., Mahamadou S. Sissoko, M.D., M.S.P.H., Amadou Niangaly, Pharm.D., Mady Sissoko, Pharm.D., Shannon Takala-Harrison, Ph.D., Kirsten E. Lyke, M.D., Yukun Wu, Ph.D., William C. Blackwelder, Ph.D., Olivier Godeaux, M.D., Johan Vekemans, M.D., Ph.D., Marie-Claude Dubois, M.Sc., W. Ripley Ballou, M.D., Joe Cohen, Ph.D., Darby Thompson, M.S., Tina Dube, Ph.D., Lorraine Soisson, Ph.D., Carter L. Diggs, M.D., Ph.D., Brent House, Ph.D., David E. Lanar, Ph.D., Sheetij Dutta, Ph.D., D. Gray Heppner, Jr., M.D., and Christopher V. Plowe, M.D., M.P.H.

N Engl J Med 2011; 365:1004-1013September 15, 2011

Abstract
Background

Blood-stage malaria vaccines are intended to prevent clinical disease. The malaria vaccine FMP2.1/AS02A, a recombinant protein based on apical membrane antigen 1 (AMA1) from the 3D7 strain of Plasmodium falciparum, has previously been shown to have immunogenicity and acceptable safety in Malian adults and children.

Full Text of Background…
Methods

In a double-blind, randomized trial, we immunized 400 Malian children with either the malaria vaccine or a control (rabies) vaccine and followed them for 6 months. The primary end point was clinical malaria, defined as fever and at least 2500 parasites per cubic millimeter of blood. A secondary end point was clinical malaria caused by parasites with the AMA1 DNA sequence found in the vaccine strain.

Full Text of Methods…
Results

The cumulative incidence of the primary end point was 48.4% in the malaria-vaccine group and 54.4% in the control group; efficacy against the primary end point was 17.4% (hazard ratio for the primary end point, 0.83; 95% confidence interval [CI], 0.63 to 1.09; P=0.18). Efficacy against the first and subsequent episodes of clinical malaria, as defined on the basis of various parasite-density thresholds, was approximately 20%. Efficacy against clinical malaria caused by parasites with AMA1 corresponding to that of the vaccine strain was 64.3% (hazard ratio, 0.36; 95% CI, 0.08 to 0.86; P=0.03). Local reactions and fever after vaccination were more frequent with the malaria vaccine.

Full Text of Results…
Conclusions

On the basis of the primary end point, the malaria vaccine did not provide significant protection against clinical malaria, but on the basis of secondary results, it may have strain-specific efficacy. If this finding is confirmed, AMA1 might be useful in a multicomponent malaria vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; ClinicalTrials.gov number, NCT00460525.)

Crizotinib, obat baru anti kanker paru

Crizotinib

crizotinib

crizotinib

On August 26, 2011, the U. S. Food and Drug Administration granted accelerated approval to crizotinib (XALKORI

crizotinib

crizotinib

Capsules, Pfizer Inc.) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The FDA approved the Vysis ALK Break-Apart FISH Probe Kit (Abbott Molecular, Inc.) concurrently with the crizotinib approval. This companion diagnostic test is designed to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in NSCLC.

The approval was based on two single arm trials, Study A (N = 136 patients) and Study B (N = 119 patients). Crizotinib, 250 mg, was administered orally twice daily to a total of 255 patients with locally advanced or metastatic ALK-positive NSCLC. Demographic analysis from the combined data of these trials noted that the median age was 52 years, 63% of patients were Caucasian, 30% were Asian, 48% were male and 84% had an ECOG performance status of 0 or 1. Fewer than 3% of patients were current smokers. Ninety-six percent had adenocarcinoma, 95% had metastatic disease, and 94% had received prior systemic treatment for NSCLC.
The primary endpoint of both trials was objective response rate (ORR) as assessed by the investigator. In Study A, the ORR was 50% (95% CI: 42%, 59%) with a median response duration of 42 weeks. In Study B, the ORR was 61% (95% CI: 52%, 70%) with a median response duration of 48 weeks. Complete responses were observed in 1% of patients. No differences in ORR by performance status, the number of prior chemotherapeutic regimens, or the percentage of cells found to have the ALK gene rearrangement were noted.
The most common adverse reactions (≥25%) observed in both studies were vision disorder, nausea, diarrhea, vomiting, edema, and constipation. Vision disorders included visual impairment, photopsia, vision blurred, vitreous floaters, photophobia, and diplopia. Grade 3-4 adverse reactions in at least 4% of patients included increased ALT and neutropenia. Crizotinib has been associated with severe, life-threatening, or fatal treatment-related pneumonitis with a frequency of 1.6% in clinical trials. All cases occurred within 2 months after the treatment initiation.
The recommended dose and schedule for XALKORI is 250 mg orally twice daily.
Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at
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).

Obat baru :Firazyr (icatibant) sebagai antiangioedema herediter

Australian Public Assessment Report for Icatibanticatibant

firazyr, icatibant, antiangioedema herediter

FDA baru saja merelease obat baru antiangiodema herediter yaitu Firazyr (icatibant). Sediaan injeksi ini diindikasikan untuk gangguan angioedema herediter. Angioedema herediter termasuk gangguan pembuluh darah yang jarang terjadi tetapi berbahaya. Dengan adanya obat baru ini maka akibat fatal akibat gangguan angioedema herediter dapat diperkecil.

Obat baru ini telah direlease oleh FDA pada tanggal 25 -08-2011. Baca selengkapnya release FDA pada sbb:

FDA NEWS RELEASE

For Immediate Release: August 25, 2011
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Firazyr to treat acute attacks of hereditary angioedema

The U.S. Food and Drug Administration today approved Firazyr (icatibant) Injection for the treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older.

HAE is caused by low levels or the improper function of a protein called C1 inhibitor, which is involved in regulating how certain immune system and blood clotting pathways function. There is usually a family history of the condition. Fewer than 30,000 people in the United States have HAE.

People with HAE can develop rapid swelling of the hands, feet, limbs, face, intestinal tract, voice box, or windpipe, which may result in disfigurement, disability, or death. Swelling of the digestive tract may cause abdominal pain, nausea, and vomiting, while airway swelling puts patients at risk of suffocation.

“Firazyr provides a new option to treat acute attacks of HAE and because it can be self-administered through an injection in the abdominal area, patients can treat themselves upon recognition of an HAE attack,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

The safety and efficacy of Firazyr was demonstrated in three controlled clinical trials, with open-label extension periods, in which 225 patients received 1,076 doses of 30 mg Firazyr. The median time for patients treated with Firazyr to report onset of symptom relief was two hours compared with almost 20 hours with placebo.

Firazyr is the third drug approved in the United States to treat HAE attacks. In October 2009 the FDA approved Berinert to treat facial and abdominal attacks of HAE, and Kalbitor was approved in December 2009 to treat acute attacks of HAE in patients ages 16 years and older.

The FDA approved Firazyr with patient counseling information that includes injection instructions. The most common side effects reported by those using Firazyr were injection site reactions, fever, increased liver enzymes, dizziness, and rash.

Firazyr is marketed by Shire Human Genetic Therapies Inc. of Cambridge, Mass.

For more information:

Approved Drugs: Questions and Answers

FDA merilis obat baru antikanker kulit

FDA approves Zelboraf and companion diagnostic test for late-stage skin cancer
Second melanoma drug approved this year that improves overall survival

The U.S. Food and Drug Administration today approved Zelboraf (vemurafenib), a drug to treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.

Zelboraf is specifically indicated for the treatment of patients with melanoma whose tumors express a gene mutation called BRAF V600E. The drug has not been studied in patients whose melanoma tests negative for that mutation by an FDA approved diagnostic.

Zelboraf is being approved with a first-of-a-kind test called the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic that will help determine if a patient’s melanoma cells have the BRAF V600E mutation.

The BRAF protein is normally involved in regulating cell growth, but is mutated in about half of the patients with late-stage melanomas. Zelboraf is a BRAF inhibitor that is able to block the function of the V600E-mutated BRAF protein.

“This has been an important year for patients with late-stage melanoma. Zelboraf is the second new cancer drug approved that demonstrates an improvement in overall survival,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “In March, we approved Yervoy (ipilimumab), another new treatment for late-stage melanoma that also showed patients live longer after receiving the drug.”

Zelboraf was reviewed under the FDA’s priority review program that provides for an expedited six-month review of drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists. Zelboraf and the companion BRAF V600E test are being approved ahead of the drug’s Oct. 28, 2011 goal date and the companion diagnostics’ Nov. 12, 2011 goal date.

Zelboraf’s safety and effectiveness were established in a single international trial of 675 patients with late-stage melanoma with the BRAF V600E mutation who had not received prior therapy. Patients were assigned to receive either Zelboraf or dacarbazine, another anti-cancer therapy. The trial was designed to measure overall survival (the length of time between start of treatment and death of a patient).

The median survival (the length of time a patient lives after treatment) of patients receiving Zelboraf has not been reached (77 percent still living) while the median survival for those who received dacarbazine was 8 months (64 percent still living).

“Today’s approval of Zelboraf and the cobas test is a great example of how companion diagnostics can be developed and used to ensure patients are exposed to highly effective, more personalized therapies in a safe manner,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health.

The FDA’s approval of the cobas 4800 BRAF V600 Mutation Test was based on data from the clinical study that also evaluated the safety and effectiveness of Zelboraf. Samples of a patient’s melanoma tissue were collected to test for the mutation.

The most common side effects reported in patients receiving Zelboraf included joint pain, rash, hair loss, fatigue, nausea, and skin sensitivity when exposed to the sun. About 26 percent of patients developed a skin-related cancer called cutaneous squamous cell carcinoma, which was managed with surgery. Patients treated with Zelboraf should avoid sun exposure.

Zelboraf is being approved with a Medication Guide to inform health care professionals and patients of Zelboraf’s potential risks.

In July 2011, the FDA issued a new draft guidance to facilitate the development and review of companion diagnostics. The guidance, currently available for public comment, is intended to provide companies with guidance on the agency’s policy for reviewing a companion diagnostic and the corresponding drug therapy.

Melanoma is the leading cause of death from skin disease. The National Cancer Institute estimated that 68,130 new cases of melanoma were diagnosed in the United States during 2010; about 8,700 people died from the disease.

Zelboraf is marketed by South San Francisco based-Genentech, a member of the Roche Group. The cobas 4800 BRAF V600 Mutation Test is manufactured by Roche Molecular Systems in Pleasanton, Calif.

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