Tag Archives: vemurafenib

Melanoma Heads Down the Genetic Pathway

The molecular profilization of melanoma is nigh. Assessment of advanced-stage, metastatic melanoma to determine whether it carries a mutation in the BRAF oncogene will turn routine soon, once physicians have the option to treat these patients with the new BRAF inhibitor drug, vemurafenib.

That might happen any day now. Reuters said on August 9  that the FDA’s approval of vemurafenib could get announced soon. Roche/Genentech submitted their NDA for vemurafenib to the FDA in May, and in June came impressive efficacy results in a phase III study that got reported at both ASCO and in a New England Journal of Medicine article.

malignant melanoma; courtesy Nephron/Wikimedia Commons

Last week, I covered the American Academy of Dermatology’s summer meeting in New York, and melanoma specialist Dr. Richard D. Carvajal from Memorial Sloan-Kettering, New York, told me that once vemurafenib was on the market, genetic analysis of advanced melanomas to find BRAF mutations would suddenly become standard of care. Once testing for one mutation starts, several more genes can easily piggyback onto the assay, which will help to further flesh out the range of genetic mutations that can exist in metastatic melanoma and provide potential targets for new drugs.

It’s becoming a well-trodden path that’s rapidly driving the treatment of advanced cancers of all kinds into the molecular-profiling era. Just a couple of weeks ago, I blogged here on how it had already transformed advanced lung cancer management. Breast cancer and colorectal cancer have an even longer history of genetic assessment, and more cancers will likely follow this route soon.

When I wrote my blog post about lung cancer in late July, I focused on the challenge to successfully treating late-stage cancer, and I said that better alternatives were lung cancer prevention, by not smoking, and earlier diagnosis, with CT screening.

Melanoma does not pose the same screening issues as lung cancer. It’s much easier to survey the skin than to peer into a person’s lungs. And the idea of melanoma prevention by sunlight avoidance and protection has transformed the way many Americans approach outdoor activity. Over the last generation or so, SPF has become a cultural touchstone.

Despite that,  cases of advanced melanoma are inevitable. Last week at the AAD meeting, Dr. Darrell S. Rigel from New York University showed evidence of a troubling, new wrinkle in melanoma epidemiology: an appreciable blip in cases that first appeared about 10 years ago in American women aged  30-34 years, a shift that Dr. Rigel attributed to an increased use of tanning salons among teenage girls that started in the 1980s.

Even if advanced-stage tumors, melanoma, or lung cancers are unstable and unlikely to respond to even the best targeted of drugs for more than a few years, those extra years of cancer control with good quality of life can make a big difference to each patient who responds to a genetically targeted treatment, Dr. Carvajal told me.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Filed under Blognosis, Dermatology, IMNG, Internal Medicine, Internal Medicine News, The Mole

Video of the Week: More Melanoma Treatments on the Way?

A closely watched experimental drug has excited melanoma oncologists and patients with a 63% reduction in the relative risk of death from metastatic melanoma when compared with standard therapy in a phase III trial that had enrolled 675 newly diagnosed patients. Vemurafenib (better known as PLX4032) targets the BRAF V600E mutation found in 40%-60% of melanoma patients. It is only the second melanoma drug to extend the lives of melanoma patients in a randomized clinical study.

The first such agent, ipilimumab (Yervoy), was approved earlier this year, and the melanoma community expects the Food and Drug Administration will award an indication to vemurafenib based on the new data from the BRIM-3 trial. We talked with Dr. Paul Chapman – lead author of the BRIM-3 study — about vemurafenib. He also hypothesized how clinicians would decide which drug — vemurafenib (assuming approval) vs. ipilimumab to use for their patients.

To read more about the BRIM-3 study and the future of melanoma treatment, visit IMNGoncology.

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Filed under Dermatology, IMNG, Oncology, Video

Video of the Week: Good News for Melanoma Finally

For a while, melanoma has been a bit of a red-headed stepchild of oncology. While advances have improved survival in a number of cancers in recent years, little progress had been made in melanoma. At this year’s ASCO annual meeting, new melnoma treatments generated a lot of buzz.

These new drugs are exciting and important because of their activity — meaning that they have an impact and clinical benefit in patients with advanced melanoma.      

Dr. Lynn Schuchter  

Overall survival was 11.2 months in melanoma patients who received  ipilimumab plus dacarbazine group and 9.1 months in the placebo plus dacarbazine group. The study was simultaneously published in the New England Journal of Medicine (2011 June 5 ;doi:10.1056/NEJMoa1104621). Ipilimumab was approved earlier this year as a first-line monotherapy treatment at a dosage of 3 mg/kg.

In another plenary presentation at ASCO, there was a 63% reduction in risk of death with vemurafenib, compared with dacarbazine alone, in metastatic melanoma patients with BRAF mutations. Vemurafenib is an investigational oral drug that inhibits BRAF kinase.

The read more about the results of these drug trials, check out the story in Skin & Allergy News

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Filed under Dermatology, IMNG, Oncology, The Mole, Video