Merck (NYSE:MRK) has received FDA approval for its blockbuster drug Keytruda, expanding its usage to another indication within non-small cell lung cancer (NSCLC).

The latest approval allows Keytruda to be used for patients with resectable NSCLC, a condition where surgical removal of tumors is possible. Keytruda can be employed as a neoadjuvant treatment before surgery, in combination with chemotherapy, and then continue as a single-agent adjuvant treatment after the surgery.

This approval is based on compelling data from the phase III KEYNOTE-671 study. The results demonstrated statistically significant improvements in event-free survival and overall survival, which are the primary endpoints of the study.

With this recent approval, Keytruda now boasts six indications for NSCLC, encompassing both metastatic and earlier stages of the disease.

Additionally, Merck has achieved a label expansion for Keytruda in NSCLC from the European Commission, marking its fifth approved indication. In this case, Keytruda, as a monotherapy, is sanctioned as an adjuvant treatment for adult NSCLC patients at high risk of recurrence following complete resection and platinum-based chemotherapy. This approval signifies the first immunotherapy option for such patients in the European Union.

Despite a 6.1% decline in Merck’s shares year-to-date, Keytruda maintains global approval for treating a multitude of cancers. Its sales continue to grow, driven by strong performance in metastatic indications and swift adoption in recent earlier-stage applications. In H1 2023, Keytruda’s sales represented over 40% of Merck’s total revenues. Keytruda presently holds approvals for addressing seven earlier-stage cancer indications in the United States.

The expansion of Keytruda into new indications and markets worldwide has further potential for sales growth. Numerous recent approvals and the anticipated launch of additional indications, particularly in earlier lines of therapy, are expected to bolster sales. In the United States, Merck anticipates that more than half of Keytruda’s growth will arise from early-stage indications (neoadjuvant/adjuvant) by 2025, comprising approximately 25% of total global Keytruda sales.

Merck’s management is actively exploring Keytruda’s potential in various indications, with promising developments across multiple studies and combination studies. If these studies lead to approvals for additional cancer indications, it will significantly contribute to sales growth.

 

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