When was Keytruda Approved for Lung Cancer?

The FDA has approved the use of Pembrolizumab (Keytruda) for treating lung cancer on several different occasions for various indications:

1. On October 16, 2023, the FDA approved Keytruda in combination with platinum-containing chemotherapy as a neoadjuvant treatment, and with the continuation of single-agent Keytruda as a post-surgical adjuvant treatment for resectable non-small cell lung cancer (NSCLC) (tumors ≥4 cm or node positive).

2. Earlier in the same year, on January 26, 2023, Keytruda received approval for use as an adjuvant treatment for NSCLC.

3. On April 11, 2019, the FDA approved Keytruda for the first-line treatment of patients with stage III NSCLC who are not eligible for surgical resection or definitive chemoradiation.

4. On June 17, 2019, it was granted priority approval for individuals with metastatic small cell lung cancer (SCLC) with tumor progression on or following platinum-based chemotherapy and at least one other prior line of therapy.

Each of these approvals was significant as it enhanced the treatment possibilities available to lung cancer patients. The most recent approval in October 2023 allowed for the use of Keytruda before and after surgery for earlier-stage non-small-cell lung cancer (NSCLC). This was particularly important as it introduced an immunotherapy-based regimen that could significantly improve the outcomes for patients with resectable NSCLC. This approval was supported by data from the Phase III KEYNOTE-671 trial, which demonstrated statistically significant improvements in both event-free survival and overall survival when compared to neoadjuvant chemotherapy alone with no post-surgery medication. The trial also indicated that treatment with Keytruda was generally safe, although side effects were common. Nonetheless, the benefits shown in the trial, including an improved event-free survival rate at two years and a notable reduction in the risk of death, underscored the potential of Keytruda to change the current treatment paradigm for resectable NSCLC.

Bibliography

1. Center. "FDA Approves Neoadjuvant/ Adjuvant Pembrolizumab for Resectable Non-Sm." U.S. Food and Drug Administration, 2023, (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-adjuvant-pembrolizumab-resectable-non-small-cell-lung-cancer)

2. Center. "FDA Expands Pembrolizumab Indication for First-Line Treatment of NSCLC." U.S. Food and Drug Administration, 2019, (https://www.fda.gov/drugs/fda-expands-pembrolizumab-indication-first-line-treatment-nsclc-tps-1)

3. "FDA Approves Keytruda Immunotherapy for Operable Lung Cancer." Cancer Health, 19 Oct. 2023, (https://www.cancerhealth.com/article/fda-approves-keytruda-immunotherapy-operable-lung-cancer)