An expanded access program is now available for pembrolizumab, Merck’s investigational anti-PD-1 immunotherapy, for eligible patients with advanced melanoma who have been previously treated with ipilimumab and, if indicated, a BRAF inhibitor. The U.S. Food and Drug Administration has agreed to the initiation of this program. The study is available on www.clinicaltrials.gov.
The program is limited to patients with advanced melanoma because that is the only patient group where we believe we have enough data on safety and efficacy.
The pembrolizumab Expanded Access Program for advanced melanoma will be administered by a partner company, Idis. Physicians in the U.S. can reach Idis at 1-855-478-4347 or at firstname.lastname@example.org.
Merck is expanding the program to other countries in 2014. Outside the U.S., physicians may contact Idis at +44 (0)1932 824 123 or email@example.com.
Pembrolizumab is an investigational therapy and is not approved for use by any regulatory agency. An expanded access program is for patients who have serious or immediately life-threatening illnesses for which no comparable or satisfactory alternate therapies are available.
Only physicians can enroll patients in the EAP. Patients should work through their physician to determine if they are eligible to enroll in the EAP.