FDA Approves Merck's Top Selling Drug, Keytruda For Expanded Use In Lung Cancer Indication

The FDA approved Merck & Co Inc's MRK Keytruda for resectable (tumors ≥4 centimeters [cm] or node-positive) non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment and 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.

The approval was based on data from the Phase 3 KEYNOTE-671 trial. The Keytruda regimen demonstrated statistically significant improvements in event-free survival (EFS) and overall survival (OS), the study's dual primary endpoints, versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo alone. 

81% 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.

Most recently, Merck reported topline data from the Phase 3 KEYNOTE-671 trial investigating Keytruda as a perioperative treatment regimen for patients with resectable stage II, IIIA, or IIIB (T3-4N2) NSCLC. The study met its dual primary endpoint of overall survival (OS).

Positive overall survival data should boost Keytruda's uptake in the perioperative setting...and that approval in this setting was an attractive commercial opportunity, Reuters noted, citing Citeline analyst.

Citing Morningstar analyst, Reuters reported that the early-line lung cancer setting to be competitive with Bristol-Myers Squibb Co's BMY Opdivo, Roche Holding AG's RHHBY Tecentriq, and AstraZeneca PLC AZN Imfinzi.

Price Action: MRK shares closed at $104.14 on Monday.