- On Tuesday, Merck & Co. won Food and Drug Administration approval for Keytruda in patients with metastatic small cell lung cancer who show disease progression after previous treatment.
- The accelerated approval, based on the tumor response rate and durability of response in studies, means the FDA may require later confirmatory data, Merck said in a statement today.
- The FDA action opens the door for Keytruda in small cell lung cancer; the immunotherapy is already indicated for treatment of non-small cell lung cancer and other conditions ranging from melanoma to lymphoma.
Keytruda (pembrolizumab) is the main driver of growth for Merck, posting sales of almost $2.3 billion in the first three months of 2019 alone. Last year, the drug brought in more than $7 billion in total sales.
The New Jersey-based drugmaker is pouring money into research of the medicine in a bid to secure even more approvals in earlier and earlier lines of treatment.
There are more than 1,000 clinical trials underway studying Keytruda “across a wide variety of cancers and treatment settings,” Merck said. Just last week, Merck announced that the FDA had approved Keytruda as a first-line therapy for metastatic or unresectable, recurrent head and neck squamous cell carcinoma.
But lung cancer is the real key for Keytruda, representing approximately 65% of the medicine’s revenue. Small cell lung cancer accounts for between 10% and 15% of all lung cancers, according to the pharma.
Keytruda is part of a class of medicines known as checkpoint inhibitors, which also includes rivals from Bristol-Myers Squibb, Roche, Pfizer and AstraZeneca. It works by targeting a protein known as PD-1, essentially keeping the protein from turning off immune cells known as T cells. The result is a boost in the body’s immune response.
While Keytruda’s explosive growth has been a boon for Merck’s sales and stock price, some analysts have questioned whether the drugmaker is too dependent on the cancer treatment. Almost half of the company’s late-stage trials involve Keytruda.