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Saturday, August 27, 2011

Non-Small Cell Lung Cancer Drug Gets FDA Nod - in Oncology/Hematology, Lung Cancer from MedPage Today

Medical News: Non-Small Cell Lung Cancer Drug Gets FDA Nod - in Oncology/Hematology, Lung Cancer from MedPage Today


"WASHINGTON -- The FDA has approved crizotinib (Xalkori), a novel targeted therapy for late-stage non-small cell lung cancer.

The Pfizer drug, an inhibitor of anaplastic lymphoma kinase, is a twice-daily pill intended for a select group of patients who express the abnormal anaplastic lymphoma kinase (ALK) gene, which causes cancer development and growth.
The FDA also approved a companion diagnostic called the Vysis ALK Break Apart FISH Probe Kid, made by Abbott Molecular, to help determine if a patient has the abnormal ALK gene.
"The approval of Xalkori with a specific test allows the selection of patients who are more likely to respond to the drug," Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research said in a press release. "Targeted therapies such as Xalkori are important options for treating patients with this disease and may ultimately result in fewer side effects."
Crizotinib's safety and effectiveness were established in two single-arm studies enrolling a total of 255 patients with late-stage ALK-positive non-small cell lung cancer. One of those studies, published in the New England Journal of Medicine last year, found that crizotinib shrank or eliminated 57% of ALK-positive non-small cell lung tumors.
The most common side effects reported in patients receiving crizotinib included vision disorders, nausea, diarrhea, vomiting, edema, and constipation."

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Extended-Release Opioid Gets FDA OK - in Neurology, Pain Management from MedPage Today

Medical News: Extended-Release Opioid Gets FDA OK - in Neurology, Pain Management from MedPage Today


"Tapentadol was also well-tolerated, the company said. Opioids can cause a number of side effects, including constipation, that may cause patients to discontinue their use.

A 2010 phase III study comparing the drug to oxycodone in patients with painful knee osteoarthritis found that tapentadol provided effective pain relief with fewer of the gastrointestinal side effects seen with oxycodone"

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Tuesday, August 23, 2011

Northwestern researchers report breakthrough in ALS research - Chicago Sun-Times

Northwestern researchers report breakthrough in ALS research - Chicago Sun-Times


"The apparent discovery of a common cause of all forms of amyotrophic lateral sclerosis — the fatal disease also known as Lou Gehrig’s disease — could give a boost to efforts to find a treatment for the fatal neurodegenerative disease, a new study by Northwestern University researchers contends.

Scientists have long struggled to identify the underlying disease process of ALS and weren’t even sure that a common disease process was associated with all forms of ALS.

In this new study, Northwestern researchers said they found that the basis of ALS is a malfunctioning protein recycling system in the neurons of the brain and spinal cord."

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Wednesday, August 17, 2011

Vemurafenib approved for the treatment of patients with unresectable or metastatic melanoma

From FDA:

On August 17, 2011, the U. S. Food and Drug Administration approved vemurafenib tablets (ZELBORAF, Hoffmann-La Roche Inc.) for the treatment of patients with unresectable or metastatic melanoma with the BRAFV600E mutation as detected by an FDA-approved test.


The approval was based primarily on an international, randomized, open-label trial in patients with previously untreated metastatic or unresectable melanoma with the BRAFV600E mutation as detected by the cobas 4800 BRAF V600 Mutation Test (Roche Molecular Systems, Inc.). This companion diagnostic test was approved by the FDA concurrently with vemurafenib’s approval.

The trial enrolled 675 patients; 337 patients were assigned to vemurafenib, 960 mg orally twice daily, and 338 were assigned to dacarbazine, 1000 mg/m2 intravenously, every three weeks. Treatment continued until disease progression, unacceptable toxicity, and/or consent withdrawal. All patients had an ECOG performance status of 0 or 1, and 95% of patients had metastatic disease. The major efficacy outcome measures of the trial were overall survival (OS) and investigator-assessed progression-free survival (PFS). Other outcome measures included confirmed investigator-assessed best overall response rate.

The median follow-up at the time of the overall survival analysis was 6.2 and 4.5 months for the vemurafenib and dacarbazine arms, respectively. Overall survival was significantly improved in patients receiving vemurafenib compared to those receiving dacarbazine (HR=0.44; 95% CI: 0.33, 0.59; p< 0.0001, log-rank test). The median survival of patients receiving vemurafenib had not been reached (95% CI: 9.6 months, not reached) and was 7.9 months (95% CI: 7.3, 9.6) for those receiving dacarbazine.

Progression-free survival (PFS) was also significantly improved in patients receiving vemurafenib (HR=0.26; 95% CI: 0.20, 0.33; p<0.0001, log-rank test). The median PFS was 5.3 (95% CI: 4.9, 6.6) and 1.6 months (95% CI: 1.6, 1.7) in the vemurafenib and dacarbazine arms, respectively. Overall response rate (complete plus partial response rates) was 48.4% (95% CI: 41.6%, 55.2%) and 5.5% (95% CI: 2.8%, 9.3%) in the vemurafenib and dacarbazine arms, respectively.



Vemurafenib was also evaluated in a single-arm, multicenter trial that enrolled 132 patients with BRAFV600E mutation-positive metastatic melanoma who had received at least one prior systemic therapy. An independent review of treatment responses demonstrated a confirmed best overall response rate of 52% (95% CI: 43%, 61%), with a median response duration of 6.5 months (95% CI: 5.6, not reached).

The most common adverse reactions (≥30%) in patients treated with vemurafenib were arthralgia, rash, alopecia, fatigue, photosensitivity reaction, and nausea. Cutaneous squamous cell carcinomas (cuSCC), including squamous cell carcinomas of the skin and keratoacanthomas, were detected in approximately 24% of patients treated with vemurafenib. CuSCCs were managed with excision in clinical trials, and patients were able to continue treatment without dose adjustment. Other adverse reactions, sometimes severe, reported in vemurafenib-treated patients included hypersensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, uveitis, QT prolongation, and liver enzyme laboratory abnormalities.

The recommended dose of vemurafenib is 960 mg, orally twice daily administered approximately 12 hours apart, with or without a meal.


Confirmation of BRAFV600E mutation-positive melanoma using an FDA-approved test is required before treatment with vemurafenib. Vemurafenib is not recommended for use in patients with wild-type BRAF melanoma. The approval also contains a Medication Guide to inform health care professionals and patients of vemurafenib’s potential risks.

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/2011/202429s000lbl.pdf

***

From Medscape:

Enthusiasms

This study is "practice changing," said Lynn Schuchter, MD, from the Abramson Cancer Center at the University of Pennsylvania in Philadelphia, who moderated the press conference.

Responses with the new oral therapy can be dramatic — patients can have improvement within 72 hours of treatment, she said.

With 2 agents — vemurafenib and ipilimumab (which is approved by the US Food and Drug Administration) — emerging as effective treatments for metastatic melanoma in the past year, it is a "time for celebration for our patients," said Dr. Schuchter — "a time for hope."

"The results of the BRIM-3 study represent a major shift in the way we think about and treat melanoma," writes Marc Ernstoff, MD, in an editorial that accompanies the published study. He is from the Dartmouth Medical School and Norris Cotton Cancer Center in Lebanon, New Hampshire.

Melanoma is a collection of heterogeneous tumors that are differentiated by means of molecular markers, says Dr. Ernstoff, and "each molecularly defined subgroup will probably have a different treatment algorithm."

For patients with metastatic melanoma and the BRAF V600E mutation, "the availability of vemurafenib is a major defining moment that will have an important effect on survival and quality of life," he summarizes.

"These are definitely absolutely remarkable results," said Petra Rietschel, MD, PhD, from the Montefiore Einstein Center for Cancer Care in the Bronx, New York. "As soon as it is on the market, I will most certainly be using it in my clinic for patients with V600E BRAF mutations," she told Medscape Medical News.

***

Via Wikipedia:


Two mechanisms of resistance to vemurafenib (covering 40% of cases) have been discovered:

  • The cancer cells begin to overexpress a cell surface protein PDGFRB creating an alternate survival pathway.
  • A second oncogene called NRAS mutates, reactivating the normal BRAF survival pathway.[6]

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Welcome and thanks for visiting Onco-P.R.N. - The oncology website with a focus on all things oncology pharmacy/pain/palliative care-related. It is intended to be an information resource for those pharmacist and relevant health care professionals involved in whatever fashion with cancer and palliative care. Stay tuned for the latest and greatest links and information with respect to: oncology medications, continuing education, pharmaceutical care initiatives, pain and symptom control, supportive care topics, and whatever else that might fit into the theme.

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Pharmacy History

"The earliest known compilation of medicinal substances was ARIANA the Sushruta Samhita, an Indian Ayurvedic treatise attributed to Sushruta in the 6th century BC. However, the earliest text as preserved dates to the 3rd or 4th century AD.
Many Sumerian (late 6th millennium BC - early 2nd millennium BC) cuneiform clay tablets record prescriptions for medicine.[3]

Ancient Egyptian pharmacological knowledge was recorded in various papyri such as the Ebers Papyrus of 1550 BC, and the Edwin Smith Papyrus of the 16th century BC.

The earliest known Chinese manual on materia medica is the Shennong Bencao Jing (The Divine Farmer's Herb-Root Classic), dating back to the 1st century AD. It was compiled during the Han dynasty and was attributed to the mythical Shennong. Earlier literature included lists of prescriptions for specific ailments, exemplified by a manuscript "Recipes for 52 Ailments", found in the Mawangdui tomb, sealed in 168 BC. Further details on Chinese pharmacy can be found in the Pharmacy in China article."

From Wikipedia: http://en.wikipedia.org/wiki/Pharmacy#History_of_pharmacy

Journal of Palliative Medicine - Table of Contents

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