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Keytruda approved as first-line melanoma treatment
Sales of Merck’s Keytruda (pembrolizumab) are expected to increase, after FDA approved the drug for first-line treatment of melanoma.
Sales of Merck’s Keytruda (pembrolizumab) are expected to increase, after FDA approved the drug for first-line treatment of melanoma.
Last September, FDA approved Keytruda – but only for patients with advanced or unresetable melanoma who are no longer responding to other drugs. With the new FDA approval, doctors will be able to prescribe Keytruda first for melanoma, which will lead to broader patient use.
Related: FDA approves Keytruda for advance melanoma
And, earlier this year, FDA granted accelerated approval for Keytruda to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1.
Related: Keytruda for lung cancer gets accelerated approval
“Data supporting the approval emerged from a large and diverse patient population, including patients with very advanced disease and patients whose tumors carried BRAF mutations, thus demonstrating both the breadth of our clinical development program for Keytruda, and the potential of Keytruda to extend the lives of those afflicted with this grievous malignancy,” said Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories.
The expanded approval came after a phase 3 trial which found that patients with unresectable or metastatic melanoma who were treated with Keytruda experienced superior overall survival compared to those treated with Yervoy (ipilimumab).
In the study, patients given Keytruda 10 mg./kg. every 2 weeks demonstrated a 37% reduction in the risk of death and those given Keytruda 10 mg./kg. every 3 weeks demonstrated a 31% reduction in the risk of death.
However, Merck issued a caution because immune-mediated adverse reactions occurred with Keytruda, including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. “Based on the severity of the adverse reaction, Keytruda should be withheld or discontinued and corticosteroids administered,” according to a statement from the company.
The most commonly reported adverse reactions were fatigue (28% with Keytruda vs. 28% with ipilimumab), diarrhea (26% with Keytruda), rash (24% with Keytruda vs. 23% with ipilimumab), and nausea (21% with Keytruda).
Drugs to Watch: Mental Health Conditions
April 11th 2024The FDA is reviewing two novel therapies: a psychedelic-assisted therapy for PTSD with a target action date of Aug. 11, 2024, and therapy for schizophrenia that does not directly block dopamine receptors with an action date of Sept. 26, 2024.
