FDA Greenlights Another Indication for Merck’s Keytruda

Merck logo on outdoor brick sign

Katherine Welles / Shutterstock.com

Merck’s blockbuster anti-PD-1 therapy Keytruda has snagged another regulatory approval from the U.S. Food and Drug Administration (FDA). The checkpoint inhibitor has been approved, in combination with chemotherapy, as a first-line treatment for patients with metastatic squamous non-small cell lung cancer (NSCLC).

Since its initial FDA approval in 2014 as a treatment for advanced melanoma, Keytruda has racked up multiple approvals for various indications, including advanced NSCLC, metastatic head and neck squamous cell carcinoma, metastatic NSCLC, classic Hodgkin Lymphoma, metastatic urothelial carcinoma, metastatic gastric or gastroesophageal junction cancer with PD-L1 expressing tumors, metastatic cervical cancer with PD-L1 expressing tumors, and relapsed primary mediastinal large B-cell lymphoma. A timeline of FDA approvals for Keytruda can be found here. It does not include approvals by other regulatory agencies, such as the European Medicines Agency (EMA).

The latest indication for which Keytruda was approved, was based on results from the Phase III KEYNOTE-407 trial that included patients regardless of tumor PD-L1 expression status. Trial results showed that Keytruda, in combination with chemotherapy treatments carboplatin and either paclitaxel or nab-paclitaxel, significantly improved overall survival, and reduced the risk of death by 36 percent compared to chemotherapy alone. In its announcement, Merck said this approval marks the first time an anti-PD-1 regimen has been approved for the first-line treatment of squamous NSCLC regardless of tumor PD-L1 expression status. Merck added that Keytruda is the first anti-PD-1 approved in the first-line setting as both combination and monotherapy in certain patients with metastatic NSCLC.

With this approval, all appropriate patients with metastatic squamous NSCLC and all appropriate patients with metastatic nonsquamous NSCLC and no EGFR or ALK genomic tumor aberrations are now eligible for a Keytruda-based regimen as their first-line treatment option, Merck said.

Roger Perlmutter, president of Merck Research Laboratories, said the latest approval for Keytruda expands the company’s lung cancer indications for with metastatic squamous non-small cell lung cancer, which is a type of lung cancer that is difficult to treat. Squamous cell lung cancer accounts for about 30 percent of all lung cancers. This type of lung cancer tends to be found in the middle of the lungs. NSCLC is the most common type of lung cancer. It accounts for about 85 percent of all cases. The five-year survival rate for patients diagnosed in the United States with any stage of lung cancer is estimated to be 18 percent, according to data shared by Merck.

“Approval by the FDA has the potential to mean that Keytruda can be used to improve survival for more patients with this debilitating disease,” Perlmutter said in a statement.

Merck said in the KEYNOTE-407 trial, the company saw a statistically significant improvement in overall survival, progression-free survival and objective response rate, which were the primary efficacy outcome measures for the Phase III trial.

Sales of Keytruda generated more than $3.8 billion for Merck in 2017.

Click here to get the latest life sciences news straight to your inbox. Subscribe now to our FREE newsletters

Back to news