New Drug Approvals

Home » EU SUBMISSION » GSK files for EU approval of trametinib for melanoma

GSK files for EU approval of trametinib for melanoma



Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 


Blog Stats

  • 4,231,785 hits

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 2,800 other subscribers

add to any




Trametinib (GSK1120212) is experimental cancer drug. It is a MEK inhibitor drug with anti-cancer activity.[1]

It inhibits MEK1 and MEK2.[1]

Trametinib had good results for V600E mutated metastatic melanoma in a phase III clinical trial.[2]

  1. Trametinib, NCI Drug Dictionary
  2. METRIC phase III study: Efficacy of trametinib (T), a potent and selective MEK inhibitor (MEKi), in progression-free survival (PFS) and overall survival (OS), compared with chemotherapy (C) in patients (pts) with BRAFV600E/K mutant advanced or metastatic melanoma (MM).

FEBRUARY 12, 2013

GSK granted speedy review for melanoma drug

The European Medicines Agency has given GlaxoSmithKline’s melanoma drug an accelerated review.

The drug – a MEK inhibitor called trametinib – is seeking a European licence as both a monotherapy and in combination with GSK’s investigational BRAF inhibitor dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has granted GSK’s request for accelerated assessment of this application, meaning it may be on the market within six months if approved.

The application includes data from a Phase III study of trametinib monotherapy compared to the established chemotherapy agents dacarbazine or paclitaxel monotherapy in patients with BRAF V600 mutation positive metastatic melanoma

It also includes data from a randomised Phase I/II study comparing dabrafenib monotherapy to combination therapy with dabrafenib and trametinib in patients with BRAF V600 mutation positive metastatic melanoma

“We initiated a randomised study very early in the development programme to test whether the novel-novel combination could circumvent resistance to single agent anti-BRAF therapy and are encouraged by the results from this Phase I/II trial,” said Dr Rafael Amado, head of oncology R&D at GSK.

“We are planning further regulatory submissions based on these data, in the US and other countries in the coming months,” he added.

An application that has been granted accelerated assessment will have a maximum review time of 150 days, although the CHMP can extend this if needs be.

In August 2012, GSK announced regulatory submissions for dabrafenib monotherapy as a treatment for BRAF V600 metastatic melanoma in Europe and the USA, as well as a US submission for trametinib monotherapy as a treatment for BRAF V600 metastatic melanoma.

Trametinib and dabrafenib are investigational medicines and their use as monotherapy or combination therapy is not approved anywhere in the world.

Roche’s Zelboraf (vemurafenib) is currently the only licensed drug to treat BRAF positive melanoma patients, and is the first drug to increase overall survival in this patient population.

GSK is currently conducting a head-head Phase III trial against Zelboraf, with both of its drugs, results of which are expected next year. If approved GSK’s drugs will also be up against Bristol-Myers Squibb’s vaccine Yervoy, which works as a cancer vaccine.

Yervoy and Zelboraf are both expected to bring in peak annual sales of around $1 – $2 billion, making the new melanoma market a potentially lucrative venture for pharma.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.


Follow New Drug Approvals on

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 2,800 other subscribers


DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with AFRICURE PHARMA as ADVISOR, earlier assignment was with GLENMARK LIFE SCIENCES LTD, as CONSUlTANT, Retired from GLENMARK in Jan2022 Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 32 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 32 PLUS year tenure till date Feb 2023, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 100 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 100 Lakh plus views on dozen plus blogs, 227 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 38 lakh plus views on New Drug Approvals Blog in 227 countries...... , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc He has total of 32 International and Indian awards

Personal Links

View Full Profile →



Follow my blog with Bloglovin The title of your home page You could put your verification ID in a comment Or, in its own meta tag Or, as one of your keywords Your content is here. The verification ID will NOT be detected if you put it here.
%d bloggers like this: