Featured Research

from universities, journals, and other organizations

FDA Approval of Revolutionary Two-Drug Combo to Treat Advanced Melanoma

Date:
January 27, 2014
Source:
Moffitt Cancer Center
Summary:
Researchers have laid the groundwork for a revolutionary new combination therapy for the treatment of advanced melanoma – melanoma that cannot be removed surgically or has spread to other areas of the body. The newly FDA-approved therapy, Mekinist (trametinib) in combination with Tafinlar (dabrafenib), is one of the biggest advancements in melanoma treatment in the past 30 years.

Moffitt Cancer Center researchers have laid the groundwork for a revolutionary new combination therapy for the treatment of advanced melanoma – melanoma that cannot be removed surgically or has spread to other areas of the body. The newly FDA-approved therapy, Mekinist (trametinib) in combination with Tafinlar (dabrafenib), is one of the biggest advancements in melanoma treatment in the past 30 years.

“Melanoma is the most aggressive type of skin cancer and the leading cause of death from skin disease,” said Jeffrey S. Weber, M.D., Ph.D., director of Moffitt’s Melanoma Research Center of Excellence. “This new combination therapy is a huge step in the right direction for the treatment of melanoma, and our researchers played a large role in bringing this treatment option to patients.”

Mekinist and Tafinlar are used to block signaling in different sites of the same molecular pathway – the MAP kinase pathway. Keiran S. Smalley, Ph.D., scientific director of the Melanoma Research Center of Excellence, and his team began investigating this pathway in 2010 and discovered the best way to block its ability to promote cancer cell growth was with combined inhibitor therapy.

The new combination therapy is indicated for melanoma patients whose tumors express gene mutations called BRAF V600E and V600K. Approximately half of all metastatic melanoma patients’ tumors have a BRAF mutation, an abnormal change that can enable melanoma tumor cells to grow and spread.

BRAF-inhibitor resistance has long been a problem in the melanoma field, but Moffitt researchers found that using two inhibitors to block different growth pathways during treatment prevented resistance in patients with this mutation.

“A clinical trial in which Moffitt was the major contributor showed a 76 percent success rate for patients treated with the Mekinist and Tafinlar combination. We also found this therapy reduced the incidence and severity of some of the toxic effects patients experienced when the drugs were used alone,” said Weber.

The FDA approved the combination of Mekinist and Tafinlar through its accelerated approval program, which allows the agency to approve drugs to treat a serious disease based on clinical data showing the therapy has a proven effect and clinical benefit to patients. The FDA also reviewed this combination of drugs under the agency’s priority review because they demonstrated the potential to be a significant improvement in safety or effectiveness in the treatment of melanoma.


Story Source:

The above story is based on materials provided by Moffitt Cancer Center. Note: Materials may be edited for content and length.


Journal References:

  1. K H T Paraiso, I V Fedorenko, L P Cantini, A C Munko, M Hall, V K Sondak, J L Messina, K T Flaherty, K S M Smalley. Recovery of phospho-ERK activity allows melanoma cells to escape from BRAF inhibitor therapy. British Journal of Cancer, 2010; 102 (12): 1724 DOI: 10.1038/sj.bjc.6605714
  2. Keith T. Flaherty, Jeffery R. Infante, Adil Daud, Rene Gonzalez, Richard F. Kefford, Jeffrey Sosman, Omid Hamid, Lynn Schuchter, Jonathan Cebon, Nageatte Ibrahim, Ragini Kudchadkar, Howard A. Burris, Gerald Falchook, Alain Algazi, Karl Lewis, Georgina V. Long, Igor Puzanov, Peter Lebowitz, Ajay Singh, Shonda Little, Peng Sun, Alicia Allred, Daniele Ouellet, Kevin B. Kim, Kiran Patel, Jeffrey Weber. Combined BRAF and MEK Inhibition in Melanoma with BRAF V600 Mutations. New England Journal of Medicine, 2012; 367 (18): 1694 DOI: 10.1056/NEJMoa1210093

Cite This Page:

Moffitt Cancer Center. "FDA Approval of Revolutionary Two-Drug Combo to Treat Advanced Melanoma." ScienceDaily. ScienceDaily, 27 January 2014. <www.sciencedaily.com/releases/2014/01/140127100949.htm>.
Moffitt Cancer Center. (2014, January 27). FDA Approval of Revolutionary Two-Drug Combo to Treat Advanced Melanoma. ScienceDaily. Retrieved April 17, 2014 from www.sciencedaily.com/releases/2014/01/140127100949.htm
Moffitt Cancer Center. "FDA Approval of Revolutionary Two-Drug Combo to Treat Advanced Melanoma." ScienceDaily. www.sciencedaily.com/releases/2014/01/140127100949.htm (accessed April 17, 2014).

Share This



More Health & Medicine News

Thursday, April 17, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Is Apathy A Sign Of A Shrinking Brain?

Is Apathy A Sign Of A Shrinking Brain?

Newsy (Apr. 17, 2014) A recent study links apathetic feelings to a smaller brain. Researchers say the results indicate a need for apathy screening for at-risk seniors. Video provided by Newsy
Powered by NewsLook.com
Could Even Casual Marijuana Use Alter Your Brain?

Could Even Casual Marijuana Use Alter Your Brain?

Newsy (Apr. 16, 2014) A new study conducted by researchers at Northwestern and Harvard suggests even casual marijuana use can alter your brain. Video provided by Newsy
Powered by NewsLook.com
Thousands Of Vials Of SARS Virus Go Missing

Thousands Of Vials Of SARS Virus Go Missing

Newsy (Apr. 16, 2014) A research institute in Paris somehow misplaced more than 2,000 vials of the deadly SARS virus. Video provided by Newsy
Powered by NewsLook.com
Formerly Conjoined Twins Released From Dallas Hospital

Formerly Conjoined Twins Released From Dallas Hospital

Newsy (Apr. 16, 2014) Conjoined twins Emmett and Owen Ezell were separated by doctors in August. Now, nearly nine months later, they're being released from the hospital. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins