Keytruda also has the potential for severe immune-mediated side effects. The most common were fatigue, cough, nausea, pruritus, rash, decreased appetite, constipation, joint arthralgia, and diarrhea. Keytruda’s safety was established in the trial population of 411 participants with advanced melanoma. A similar percentage of patients had their tumor shrink at the 10 mg/kg dose. This effect lasted at least 1.4 to 8.5 months and continued beyond this period in most patients. ![]() In the half of the participants who received Keytruda at the recommended dose of 2 mg/kg, approximately 24% had their tumors shrink. All participants were treated with Keytruda, either at the recommended dose of 2 milligrams per kilogram (mg/kg) or at a higher dose of 10 mg/kg. Keytruda’s efficacy was established in 173 clinical trial participants with advanced melanoma whose disease progressed after prior treatment. It also received priority review and orphan product designation. The five prior FDA approvals for melanoma include: ipilimumab (2011), peginterferon alfa-2b (2011), vemurafenib (2011), dabrafenib (2013), and trametinib (2013).?The FDA granted Keytruda breakthrough therapy designation because the sponsor demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies. Keytruda is the sixth new melanoma treatment approved since 2011. For melanoma patients whose tumors express a gene mutation called BRAF V600, Keytruda is intended for use after treatment with ipilimumab and a BRAF inhibitor. Keytruda is intended for use following treatment with ipilimumab, a type of immunotherapy. Keytruda is the first approved drug that blocks a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells. ![]() The US Food and Drug Administration granted accelerated approval to Merck & Co’s Keytruda (pembrolizumab) for patients with advanced or unresectable melanoma who are no longer responding to other drugs.įor melanoma patients whose tumors express a gene mutation called BRAF V600, Keytruda is intended for use after treatment with ipilimumab and a BRAF inhibitor.
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