Anti PD1 infomation -MK-3475
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http://www.merck.com/about/MK-3475.html MK-3475: U.S. Expanded Access Program Now Available, Other Countries to Start in 2014
Published: March 10, 2014
Message from Roger Perlmutter
One of Merck’s top priorities is to accelerate the development of MK-3475 to bring this investigational medicine to as many patients who may benefit as we can, as soon as we can. Our first priority is always to ensure that we conduct the clinical trials that are required by the regulatory authorities and that answer important questions about the potential risks and benefits of our new medicines. These authorities need these answers in order to approve our medicines, and physicians need these answers in order to decide which medicines to choose for their patients. That is why enrollment in clinical trials is our priority; it’s why we encourage eligible patients to enroll; and it’s why we are very grateful to patients and investigators for their participation.
Whenever possible, we also want to help in cases where diseases are immediately life-threatening and alternatives for treatment are either absent completely or have been exhausted. That’s why if one of our medicines has shown evidence of benefits outweighing risks in a potential indication; we are also committed to helping those with the relevant disease who are not eligible to participate in a clinical trial. We do this through our Expanded Access Programs (EAPs).
Merck has initiated an Expanded Access program in the U.S. for MK-3475, our investigational anti-PD-1 immunotherapy. The program is available to eligible patients with advanced melanoma who have been previously treated with ipilimumab and, if indicated, a BRAF inhibitor. The program is now open in the United States, and we will be expanding to other countries this year.
Expanded access programs are for patients who have serious or immediately life-threatening illnesses for which there are no other comparable or satisfactory therapeutic options. (See our public policy on access to our investigational medicines.)
While clinical trials are always our first priority, because they are the best way to ensure broad access for patients who might benefit from our therapies – we initiated the MK-3475 advanced melanoma expanded access program to address an unmet medical need.
We want to thank the many people throughout Merck who have enabled us to implement this program – as we continue to work toward the additional milestones ahead of us in our quest to bring MK-3475 to patients throughout the world. MK-3475 is being studied across a number of cancer types, and we will continue to share results with the medical community as they become available.
If you receive a call or an email from a physician or patient regarding the MK-3475 Advanced Melanoma expanded access program, please refer them to our program partner, Idis, at:
•In the U.S.: 1-855-478-4347 or via e-mail at
mk3475us@idispharma.com •Outside of the U.S.: +44 (0)1932 824 123 or via email at
mk3475row@idispharma.com .Idis will be maintaining a list of those who have inquired about the program, including individuals from countries where the program has yet to be initiated – so it is essential that all inquiries be routed to them.
Thank you.
are the terms ‘expanded access’ and ‘compassionate use’ used interchangeably by drug companies? I know Merck just opened an expanded access for its 3475 drugs but what about compassionate use?
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