First Treatment Approved Under EAMS
News Mar 13, 2015
MRC Technology (MRCT) has highlighted that the first drug to be approved through the Early Access to Medicine Scheme (EAMS) has been named as pembrolizumab, an immunotherapy treatment for advanced melanoma.
The treatment has been developed by Merck, known as MSD outside the United States and Canada, with early development work carried out using MRC Technology’s antibody humanization expertise.
Pembrolizumab is considered a next generation drug in cancer care, stimulating the body’s immune system to fight the disease. The therapeutic is one of a new generation of PD-1 (programmed cell death protein 1) therapies that block the biological pathways cancers use to disguise themselves from the immune system.
It acts by making the cancer cell ‘visible’ to the immune system and the cell can thus be destroyed by the body’s natural defence mechanisms. UK based scientists at MRCT, with extensive expertise in antibody engineering techniques, first advanced the antibody-based treatment and carried out humanization, an essential step in the success of the therapeutic.
EAMS is a new NHS system enabling drugs to be fast-tracked to patients. The scheme has been set up to give severely ill patients rapid access to promising unlicensed medicines, meaning that this drug is available to be prescribed to patients much earlier than it would normally have been before EAMS was established.
Dave Tapolczay, Chief Executive Officer, MRC Technology said: “We are very proud of our role in bringing this new cancer treatment to patients with highly invasive tumours. Making pembrolizumab available under the Early Access to Medicines Scheme (EAMS) is another big step in getting healthcare innovation to patients sooner and underlines our commitment to improving lives through science.”
Dr Justin Bryans, Director of Drug Discovery, MRC Technology said: “Pembrolizumab is different from other cancer drugs, as it boosts the immune system to launch an attack on cancer cells, rather than destroying cancer cells directly. MRC Technology scientists humanized the antibody so it would not be recognized and hence destroyed by the immune system. The PD-1 pathway allows cancer cells to escape detection by the body’s immune response. The antibody blocks this pathway leaving cancer cells susceptible to attack and destruction by the immune system.”
MRC Technology has humanized over 55 antibodies to date, including four marketed products, Tysabri (natalizumab), Actemra (tocilizumab), Entyvio (vedolizumab) and Keytruda (pembrolizumab). A further five are in clinical trials and two more in preclinical studies.
Pembrolizumab received FDA (USA) approval in September 2014 and is commercially available in the United States as Keytruda. An application for European (EMA) approval was made in June 2014.