FDA Accepts Biologic Application for Keytruda Treatment of Lung Cancer

The FDA recently accepted Merck’s Biologics License Application (BLA) for its cancer medication Keytruda. Promising results from interim clinical trial data indicated that Keytruda improved survival for patients with stage II or IIIA non-small cell lung cancer. FDA officials have set a target action date of January 29, 2023, subject to the need for additional data.  

Keytruda is being tested in the KEYNOTE clinical trials, which have already had success earning Merck several FDA approvals. The ongoing study of Keytruda in non-small cell lung cancer hopes to show an improved rate of disease-free survival and safety for using Keytruda in early-stage cancer patients. Trials will work in tandem with the European Organization for Research and Treatment of Cancer and the European Thoracic Oncology Platform.   

Merck has previously received FDA approval to use Keytruda to treat several cancers. In July of 2021, the FDA signed off on Keytruda for treating endometrial carcinoma — cancer beginning in the uterus — and triple-negative breast cancer. Around the same time, Keytruda’s indication was expanded to include cutaneous squamous cell carcinoma.  

Keytruda has now received indications for treating 17 types of cancer since its introduction in 2014 and is being studied worldwide in more than 1,700 clinical trials. 

The drug is an example of a monoclonal antibody used for the targeted therapy of cancers. Keytruda operates in the body as a form of immunotherapy, enabling one’s immune system to target and kill cancer cells. It affects the programmed-death or PD-1 pathway of T cells and activates them so they may serve a role in shrinking tumors.  

Keytruda can sometimes reduce the inhibition of the immune system so much as to enable it to attack a patient’s internal organs or tissue. These types of immune-mediated adverse reactions can be fatal and may occur at any point during a patient’s use of Keytruda. In 2017, the FDA halted two clinical trials that paired Keytruda with dexamethasone and an immunomodulatory agent for treating multiple myeloma because of the increased risk of death associated with the treatment.  

Merck initially priced the monoclonal antibody treatment at $12,500 per patient per month and has since lowered the price slightly to $10,478 per month. The drug is one of the world’s best-selling medications, generating $17.2 billion in revenue in 2021 alone. Several companies are currently developing biosimilar medications that could reduce medical spending on important immunotherapies like Merck’s Keytruda.