Keytruda Approvals: A Timeline


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One month after Merck touted the strength of Keytruda as a tent-pole medication, the checkpoint inhibitor earned approval for its 22nd indication from the U.S. Food and Drug Administration.

Six years after it was first launched, Keytruda has become one of the best-selling drugs in the world. Last year, it generated more than $7 billion in revenue for Merck and that is only predicted to grow, particularly as the drug wins approval for new indications. During an Investor’s Day conference in June, Merck Chief Commercial Officer Frank Clyburn said in a short time, Keytruda has become a foundational cancer treatment.

“We have activity across 25 different cancer types… and Keytruda is changing the way in which patients are being treated today,” Clyburn said.

Keytruda picked up its latest approval at the end of July. The checkpoint inhibitor was approved as a monotherapy for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 with disease progression after one or more previous lines of systemic therapy. It marked the first anti-PD-1 therapy approved for this indication.

Keytruda was in development for years. But, after the drug picked up its first approval, it kept gaining steam. Here’s a timeline for FDA approvals.

2014 -- For Keytruda (pembrolizumab) the regulatory approval train got underway in 2014 with its first FDA win for treating advanced melanoma patients who carry a BRAF mutation.

2015 -- Then, one year later in October 2015, Keytruda picked up its second approval as a treatment for patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and whose tumors expressed the PD-L1 protein. Later that year, Keytruda won an expanded indication for the treatment of patients with advanced melanoma.

2016 – Like 2015, Keytruda picked up two approvals in 2016. In August, it was approved as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma. Then, in October, it was approved as a first-line treatment for certain patients with metastatic NSCLC.

2017 – Things really picked up steam for Keytruda in 2017. The drug nabbed five approvals that year. It started in March when the FDA approved Keytruda as a treatment for Classical Hodgkin’s Lymphoma. Then in May, Keytruda nabbed three different approvals within the span of two weeks. On May 10, the drug was approved as a first-line combination therapy for patients with metastatic NSCLC regardless of PD-L1 Expression. Then, on May 18, Keytruda was approved for certain patients with locally advanced or metastatic urothelial carcinoma. On May 23, Merck won approval for Keytruda as the first cancer treatment for any solid tumor with a specific genetic feature. When it won approval for this indication, Merck noted it marked the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. In September, Keytruda was then approved for previously treated patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction cancer whose tumors express PD-L1.

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2018 – The next year, Keytruda won approval for six more indications in the United States. The first approval came in June 2018. The FDA greenlit Keytruda for previously treated patients with recurrent metastatic cervical cancer whose tumors express PD-L1. One day later, the FDA approved Keytruda for the treatment of refractory or relapsed primary mediastinal large B-cell lymphoma. In August, the FDA approved Keytruda for patients with metastatic NSCLC with no EDFR or ALK genetic tumor aberrations. In October, Keytruda won approval in combination with carboplatin and either paclitaxel or nab-paclitaxel for first-line treatment of patients with metastatic NSCLC. In November, it was approved for hepatocellular carcinoma patients who have previously been treated with Sorafenib, a protein kinase inhibitor. The year closed out in December with an approval for treatment of patients with recurrent locally advanced or metastatic Merkel Cell carcinoma.

2019 – So far this year, Keytruda has won six separate approvals from the FDA. In February, Keytruda was approved for the adjuvant treatment of patients with melanoma with involvement of lymph nodes following complete resection. In April, it earned an expanded monotherapy label for first-line treatment of NSCLC. Also in April, it was approved in combination with Inlyta (axitinib) as a first-line treatment for patients with advanced renal cell carcinoma. In June, Keytruda snagged two approvals. First, it was approved for the treatment of metastatic small cell lung cancer. That month it was also approved for first-line treatment of head and neck squamous cell carcinoma. Finally, Keytruda won its latest approval in July for esophageal cancer.

If Clyburn’s predictions hold up, Keytruda will continue to notch approvals for some time.

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