Company: Merck & Co.
Used for: Melanoma, non-small cell lung cancer, head and neck squamous cell cancer, Hodgkin lymphoma, large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, renal cell carcinoma, endometrial carcinoma
2019 sales: $11.1 billion
After six years on the market, Merck & Co.'s PD-1/L1 superstar has firmly entrenched itself as one of pharma's global bestsellers with a raft of approved indications. But sometimes the rich get even richer, and 2020 could turn out to be a massively profitable year for Keytruda.
Keytruda could add $3.29 billion in worldwide sales to its 2019 haul of $11.1 billion, according to EvaluatePharma, bringing its total for 2020 to $14.39 billion.
To take that leap, Keytruda will springboard off of seven new FDA approvals it won in 2019 and another in January 2020.
The roll of approvals started in February 2019, when Keytruda scored an FDA nod to treat melanoma with lymph node involvement.
After that, Merck won FDA approvals as a first-line treatment for metastatic non-small cell lung cancer in April 2019; as a combo therapy with Inlyta in renal cell carcinoma later that month; as a solo and combo treatment for previously untreated head and neck cancer in June; and as a solo treatment for previously treated small-cell lung cancer a week later.
In the second half, it collected green lights as a solo therapy for locally advanced or metastatic squamous cell carcinoma in July; and, to close out the year, as a combo therapy for certain advanced endometrial carcinoma in September.
The drug followed up that winning streak with an FDA approval in early bladder cancer in January.
And more could well be on the way. Keytruda is being evaluated in a suite of phase 3 studies, including in biliary tract cancer, urinary tract cancer, colorectal cancer, mesothelioma, nasopharyngeal cancer, ovarian cancer, and prostate cancer. Most recently, in February, a combo of Keytruda and chemo topped solo chemo at staving off disease progression in triple-negative breast cancer patients with certain levels of biomarker PD-L1.
While Merck has ridden Keytruda's massive success into rarefied air, there are concerns that the immuno-oncology star could soon reach its peak with competitors piling into the field.