MLHW (Japan) approves Keytruda for adjuvant treatment of stage IIB and stage IIC melanoma afer complete resection
Merck Inc., announced that Keytruda Merck’s anti-PD-1 therapy, received four new approvals from Japan’s Ministry of Health, Labor and Welfare (MHLW) including Keytruda as monotherapy for the adjuvant treatment of patients with stage IIB or IIC melanoma after complete resection, based on data from the KEYNOTE-716 trial
The expanded indication for Keytruda as monotherapy for the adjuvant treatment of patients with stage IIB or IIC melanoma after complete resection is based on results of the Phase III KEYNOTE-716 trial, in which Keytruda as adjuvant treatment significantly prolonged recurrence-free survival, reducing the risk of disease recurrence or death by 35% (HR=0.65 [95% CI, 0.46-0.92]; p=0.00658) compared to placebo in these patients. With this expansion, Keytruda is now approved for the adjuvant treatment of resected stage IIB, IIC and stage III melanoma.
The Japanese package insert states that in KEYNOTE-716, adverse reactions were observed in 400 patients (82.8%) out of the safety analysis set of 483 patients (including 2/2 Japanese patients) receiving Keytruda at a dose of 200 mg every three weeks. The most common adverse reactions ( greater than 10%) were pruritus (24.2%), fatigue (21.1%), diarrhea (18.6%), arthralgia (16.1%), rash (15.7%) and hypothyroidism (15.5%).
Melanoma, the most serious form of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. In Japan, the rates of skin cancer have been rapidly increasing, and it is estimated there were more than 1,500 new cases of melanoma diagnosed and nearly 700 deaths from the disease in Japan in 2020.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins