Keytruda Receives 40th FDA Approval

This week marked a significant milestone in the fight against cancer. On June 17, the FDA approved the cancer immunotherapy drug, pembrolizumab (Keytruda®), combined with chemotherapy, for the treatment of adult patients with primary advanced or recurrent endometrial cancer.

This marks the 40th approval for Merck‘s drug, which has already been approved for treating various cancers, including multiple melanoma, non-small cell lung cancer (NSCLC), liver, colorectal and triple negative breast cancer.

Pembrolizumab, or Keytruda, is a monoclonal antibody that belongs to a class of drugs blocking the PD-1/PD-L1 signaling pathway to enhance the anti-tumor immune response. It targets the PD-1 protein on the surface of immune T cells, essentially “taking the brakes off” the immune system, to help eradicate tumors. Pembrolizumab was invented by scientists at the American biopharma company Organon in 2006, which was acquired by Merck in 2009 after a series of takeovers.

In 2013, Merck applied for and won the breakthrough therapy approval for Keytruda.

In September 2014, the FDA approved pembrolizumab under the fast-track development program for treating advanced melanoma patients who carry BRAF mutations and have been treated with ipilimumab and BRAF inhibitors.

In 2015, pembrolizumab was approved for its second indication for the treatment of metastatic non-small cell lung cancer (NSCLC) in people whose tumors express PD-L1 and who have failed treatment with other chemotherapeutic agents.

This new approval is based on data from the Phase 3 NRG-GY018 trial, also known as KEYNOTE-868. Results reported last year in the New England Journal of Medicine showed a 70% lower risk of disease progression when patients were treated with pembrolizumab and chemotherapy.

Research shows that endometrial cancer has an increasing number of patients and cancer-related mortality. It is projected to become the third-most prevalent cancer and the fourth-leading cause of death in women by 2040.

Currently, pembrolizumab is also approved for two additional uses in treating adult patients with advanced endometrial cancer who have not responded to previous treatments and cannot undergo surgery or radiation. Over the past ten years, Keytruda has been approved for multiple indications, reaching 40 with this latest approval.

Keytruda has proven to be a revolutionary immunotherapy drug that has saved thousands of lives worldwide. Due to its potential for treating various types of cancer, it is listed on the World Health Organization’s list of essential medicines.

Multiple clinical trials are underway to test the efficacy and success of Keytruda in different indications, either as a single agent or in combination with other therapies for different types of cancers.

With revolutionary drugs like Keytruda that harness the power of our immune system to fight cancer, a world immune to cancer is a vision well within reach.