Keytruda Reaches Milestone with Fifth FDA Approval for Non-Small Cell Lung Cancer

Merck’s revolutionary cancer treatment, Keytruda (pembrolizumab), has been officially approved by the FDA for the treatment of stage IB, II or IIIA non-small cell lung cancer after resection or platinum-based chemotherapy. This groundbreaking advancement in medical technology is set to revolutionize the fight against this deadly disease.

Merck & Co’s cancer immunotherapy, Keytruda, has been approved by the FDA for use in both metastatic and adjuvant non-small cell lung cancer (NSCLC), regardless of PD-L1 expression status. This makes Keytruda the only immunotherapy to be approved for both stages of the disease and regardless of PD-L1 status, according to a press release from the company. This is a huge breakthrough in cancer treatment, as it provides a much needed treatment option for millions of patients.

The blockbuster drug has now achieved its fifth approval in the field of Non-Small Cell Lung Cancer (NSCLC). Since its initial approval in October 2015 for advanced NSCLC, this miraculous medication has gone on to receive further endorsements for various stages of the disease and in combination with other medicines. This incredible progress has been truly remarkable.

The KEYNOTE-091 trial, a randomized, triple-blinded and placebo-controlled Phase III study, has yielded impressive results that have paved the way for Thursday’s approval. This study achieved its primary endpoint, significantly improving the investigator-assessed disease-free survival rate – the main efficacy metric. This breakthrough is a major step forward in the fight against cancer.

Adjuvant platinum-based chemotherapy was found to have a significantly beneficial effect on patients’ disease-free survival (DFS). Patients in the Keytruda arm had a median DFS of 58.7 months, compared to just 34.9 months in the placebo arm – a 27% reduction in risk of death or recurrence. This remarkable improvement in patient outcomes demonstrates the potential of this treatment to improve the lives of cancer patients.

Surgery remains the gold standard for treating stage IB, II, and IIIA non-small cell lung cancer (NSCLC), according to Roy S. Herbst, M.D., Ph.D., deputy director and chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital. With a wide range of treatments available, it is important to discuss the best option for each individual patient with their healthcare team.

For those who have battled cancer, the latest Keytruda approval could be a game-changer. Despite tremendous progress in treatments, cancer recurrence is still a major concern. This new approval gives hope to those who have fought hard against cancer and wish to maintain their hard-won progress. Keytruda has the potential to help these patients stay in remission and enjoy a healthier future.

In the KEYNOTE-091 trial, side effects such as hypothyroidism, hyperthyroidism and pneumonitis were observed in many patients. Sadly, two patients succumbed to myocarditis as a result of the trial. Despite these unfortunate events, the adverse effects reported in this trial are largely consistent with those observed in previous trials.

Keytruda, Merck’s premier PD-1 checkpoint inhibitor, has seen unprecedented success, having earned more than $15 billion in revenue by the end of the third quarter of 2022. Not only is the drug approved to treat non-small cell lung cancer, but it has also been cleared for Hodgkin lymphoma, melanoma, colorectal cancer, cervical cancer, breast cancer, and hepatocellular carcinoma, among other indications.

At the 41st J.P. Morgan Healthcare Conference, Merck unveiled its plans for the coming year, with Keytruda at the center of their growth strategy. The company is looking to solidify Keytruda’s role as a go-to anti-PD-1 therapy for cancer, both on its own and in combination with other treatments. It’s an exciting move that could redefine the future of cancer care.

Two Hits and a Miss 

Keytruda capped a whirlwind week with its Thursday approval, having presented back-to-back data drops for the drug just the day before. It’s been a fast-paced journey for the medication and it’s exciting to see the results of its hard work.

Merck’s Keytruda has achieved success in the Phase III KEYNOTE-966 trial, demonstrating its potential as a powerful first-line therapy for advanced or unresectable biliary tract cancer. By combining Keytruda with gemcitabine and cisplatin, the trial met its primary efficacy endpoint, and Merck is now planning to share the results with regulatory authorities.

Merck’s Keytruda, a promising cancer drug, suffered an unexpected setback in the Phase III KEYNOTE-991 study, where it failed to improve overall survival and radiographic progression-free survival in patients with metastatic hormone-sensitive prostate cancer. Furthermore, Keytruda caused more grade 3-5 adverse and serious adverse events than placebo. Despite this setback, the drug continues to be a promising cancer treatment option.

Merck has decided to end a clinical trial based on the advice of an independent Data Monitoring Committee, who concluded that the trial was no longer showing promising results.

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