The Food and Drug Administration has authorized Keytruda, a new Merck & Co. Inc. medication, to treat cancer patients with solid tumors that have withstood three standard-of-care drugs.
The FDA fast-tracked the approval process, which evaluated data from five preliminary clinical trials, according to a release. Keytruda attacks solid tumors containing corrupt DNA sequences that lack the ability to self-repair. These tumors are found in colorectal and other cancers.
The medication, which is still being double-checked, has side effects that include pneumonitis and hepatitis.
Dr. Luis A. Diaz Jr. of the Memorial Sloan Kettering Cancer Center hailed the approval as a step forward in treating a wide variety of hard-to-cure tumors.
“This approval for Keytruda is a transformational milestone in our progress toward personalized immunotherapy offering certain patients with difficult-to-treat cancers a medicine based on the genetic makeup of the tumor – regardless of tumor type,” Diaz said in a press release.
Merck’s president, Dr. Roger M. Perlmutter, said the new drug is a landmark achievement in designing treatment based on a tumor’s genetic signatures.
“The FDA’s approval of this first-of-its-kind, tumor-agnostic, indication is further evidence of Merck’s commitment to helping people with difficult-to-treat cancers, and to advancing the use of biomarkers to guide clinical decision-making,” Perlmutter said.
Perlmutter thanked researchers and families who helped the drug get approved.
“This is a remarkable time in the field of oncology and we are thankful to the researchers, especially the scientists and clinicians at Johns Hopkins University for their important scientific work, as well as the patients and their families who helped make today’s approval possible,” he added.