PD-1 Monoantida KEYTRUDA: FDA approved for the first treatment of recurrent or metastatic skin squamous cell carcinoma

Merck announced that the U.SFood and Drug AdministrationAdministration(
FDA) has approved its anti-PD-1 monoanti-keyTRUDA as a monodrug therapy for patients with recurrent or metastatic skin squamous cell carcinoma (cSCC) who cannot be treated with surgery or radiationThe approval is based on data from the KEYNOTE-629 Phase 2 trial, in which KEYTRUDA exhibits statistically significant efficacy and reaction persistence, with an objective response rate (ORR) of 34%, a full response rate of 4% and a partial response rate of 31%In patients who responded, 69% continued to respond for six months or more"Skin squamous cell carcinoma is the second most common form of skin cancer," said DrJonathan Cheng, vice president of clinical research atMerckIN KEYNOTE-629, THE TREATMENT OF KEYTRUDA PRODUCED A CLINICALLY MEANINGFUL AND LASTING RESPONSEToday's approval is good news for cSCC patients and further validates our commitment to bringing new treatment options to terminal, refracted cancer patients"
keyTRUDA may have serious or fatal adverse reactions mediated byimmune, including pneumonia, colitis, hepatitis, endocrine disease, nephritis and renal insufficiency, severe skin reactions, solid organ transplant rejection, and complications of ahosome hematopoieticstem celltransplantation (HSCT)Depending on the severity of the adverse reaction, KEYTRUDA should be discontinued and corticosteroid hormones given as appropriateKEYTRUDA may also cause severe or life-threatening infusion-related reactionsAccording to its mechanism of action, KEYTRUDA can cause fetal harm by taking it to pregnant women