Merck & Co. Seek FDA Approval for Melanoma Drug Keytruda
Merck & Co., Inc. (NYSE:MRK) has announced that it has submitted an application to the U.S. Food and Drug and Administration (FDA) seeking approval for its cancer drug Keytrada that is designed to treat patients with non-small cell lung cancer (NSCLC) after a study comparing the drug against rival cancer treatments by Bristol-Myers Squibb Co. was published yesterday.
The results of the study, which were presented during an American Association for Cancer Research meeting on Sunday and published in the New England Journal of Medicine (NEJM), showed Keytruda to be an effective treatment option for both lung cancer and skin cancer, also called melanoma. The drug proved to be more effective than Bristol-Myers’ melanoma drug Yervoy.
The study evaluated Keytruda against Yervoy, which has been the standard first-line option to treat advanced melanoma since its launch in 2011, in over 830 patients suffering from melanoma which had spread to various parts of their bodies.
Although Keytruda and Yervoy are both immunotherapies, the two drugs function differently. Keytruda (pembrolizumab) is among the new class of cancer drugs called PD-1 inhibitors, which work by blocking Programmed Death receptor (PD-1), the protein which blocks the immune system in cancer patients.
“The treatment paradigm for patients with advanced melanoma should be changed because a PD-1 antibody up front is beneficial,” said Antoni Ribas, professor of oncology at UCLA’s Jonsson Cancer Center, co-author of the NEJM paper, and one of the leaders of the Merck-funded study. “It has a higher response rate and a better safety profile.”
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Keytruda received FDA approval in September 2014, as a treatment for melanoma patients who witnessed worsened condition of their disease after receiving Yervoy. Merck now plans to submit an application with the FDA for approval as a first-line treatment for metastatic melanoma. President of Merck’s research arm, Roger Perlmutter, mentioned that the results from the new study demonstrate Keytruda as “the favored drug” in first-line treatment.
Dubai's new smart neuro spinal hospital: need to know
We take a look at Dubai's new smart hospital.
What: The Neuro Spinal Hospital and Radiosurgery Centre is a new hospital featuring state-of-the-art technology for spinal, neurosurgical, neurological, orthopaedic, radiosurgery and cancer treatments. The 700 million AED hospital, (equivalent to £138 million), has 114 beds, smart patient rooms, and green spaces for patient rehabilitation, and is four times the capacity of its former premises in Jumeirah. It is also the UAE’s first hospital to have surgical robots.
Where: The hospital is located in the Dubai Science Park. Founded in 2005, Dubai Science Park is home to more than 350 companies from multinational corporations in life sciences, biotechnology and research; over 4,000 people work here each day.
Who: The UAE's Neuro Spinal Hospital and Radiosurgery Centre was first established in Jumeirah in 2002 by Dr. Abdul Karim Msaddi, as the first as the first "super-specialty" neuroscience hospital.
Why: With advanced diagnosis and robotics, the hospital will provide care across neuroscience, spine, orthopaedics and oncology for people residing in the UAE, as well as international patients.
Prof. Abdul Karim Msaddi, Chairman and Medical Director of the hospital, said: “We are proud to bring world-class healthcare services to Dubai and believe our next-generation hospital will be a game-changer for the emirate’s and the region’s medical industry.
"It will not only significantly increase the availability of specialist neuroscience and radiosurgery treatments and provide better patient care but help attract and develop local and international talent. Investing in the new centre represents our continued faith in the resilience of the region’s economy, as well as a testament to our ongoing drive towards healthcare innovation in the UAE.”