FDA Approves KEYTRUDA® (pembrolizumab) for Treatment of Patients With Resectable (T≥4 cm or N+) NSCLC in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as a Single Agent as Adjuvant Treatment After Surgery
With this approval, KEYTRUDA has six indications in NSCLC, across both metastatic and earlier stages of NSCLC.
- With this approval, KEYTRUDA has six indications in NSCLC, across both metastatic and earlier stages of NSCLC.
- The EFS results, which were from the first interim analysis, were published in June 2023 in the New England Journal of Medicine.
- Adverse reactions occurring in patients with resectable NSCLC receiving KEYTRUDA in combination with platinum-containing chemotherapy, given as neoadjuvant treatment and continued as single agent adjuvant treatment, were generally similar to those occurring in patients across tumor types receiving KEYTRUDA in combination with chemotherapy.
- Eighty-one percent of patients in the KEYTRUDA in combination with platinum-containing chemotherapy arm had definitive surgery compared to 76% of patients in the placebo in combination with platinum-containing chemotherapy arm.