Merck & Co. (MRK) Announces FDA’s Grant of Breakthrough Therapy Designation for Calderasib

Merck & Co., Inc. (NYSE:MRK) is one of the top 10 undervalued blue chip stocks analysts recommend for smart investing. Merck & Co., Inc. (NYSE:MRK) announced on May 29 that calderasib (MK-1084), in combination with KEYTRUDA®, which is the company’s anti-PD-1 therapy, has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer with KRAS G12C-mutation and expressing PD-L1. Calderasib is an investigational oral specific KRAS G12C inhibitor, and this marks the first Breakthrough Therapy designation for calderasib, supported by positive data from the Phase 1 KANDLELIT-001 trial.

Dr. Shweta Jain, vice president, global clinical development, Merck Research Laboratories, stated that the Breakthrough Therapy designation for calderasib highlights the “promising potential of this medicine and unmet need for certain patients with KRAS G12C-mutated NSCLC.” Merck & Co., Inc. (NYSE:MRK) clarified that the FDA’s Breakthrough Therapy designation is granted to accelerate the development and review of medicines intended for the treatment of serious or life-threatening conditions.

Merck & Co., Inc. (NYSE:MRK) is a biopharmaceutical company that delivers health solutions to advance the treatment and prevention of diseases in animals and people. Its Pharmaceutical segment offers vaccines and human health pharmaceutical products, typically therapeutic and preventive agents. Its Animal Health segment develops, discovers, manufactures, and markets a range of vaccines and veterinary pharmaceutical products. The company’s medicine KEYTRUDA may treat certain cancers by working with the immune system.

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