FDA Grants Moderna/Merck Therapy Breakthrough Status

On 22 February 2023,Moderna and its partner Merck announced that Moderna's MRNA cancer vaccine MRNA-4517/V940 and Merck's Keytruda(R) cancer therapy have been granted breakthrough therapy status by the U.S. Food and Drug Administration.That means the FDA will fast-track its review of the new combination therapy.The Moderna cancer vaccine,when administered with Merck's Keytruda(R) cancer therapy following complete surgical resection,prevented recurrence of advanced melanoma skin cancer (stage III/IV) in 44% of patients in a Phase 2b clinical trial.Preliminary breakthrough designations are given when evidence indicates that the product may demonstrate substantial improvement over available therapies on at least one clinically significant endpoint. The new therapy is given for the adjuvant (prevention of cancer returning) treatment of patients with high-risk melanoma following complete surgical resection (removal).The two companies are to begin a Phase 3 clinical trial of the novel therapy.Moderna and Merck want to investigate the new therapy as an adjuvant treatment for other forms of cancer,including non-small cell lung cancer.* Earlier,the FDA granted breakthrough status to Moderna's MRNA vaccine against respiratory syncitial virus (RSV) which proved highly effective (more than 80%) at preventing RSV in a clinical trial.RSV is a serious threat primarily to children younger than five and older adults.RSV is the leading cause of hospitalization of babies.In the US,it kills an estimated 100-500 children a year and about 14,000 adults a year,but the estimate is suspected to be lowball.* Merck & Co Inc (MRK),Moderna Inc (MRNA)