USFDA approves New drug KEYTRUDA ( used in Melanoma) for NSCLC.

By Dr Deepu
  • The U.S. Food and Drug Administration approved Merck & Co.’s Keytruda for the treatment of the most common form of lung cancer, the second of a costly new wave of immune-boosting drugs to be cleared for one of the deadliest cancer types.
  • The FDA cleared Keytruda for use in patients with non-small-cell lung cancer whose tumors contain a certain level of a protein known as PD-L1.
  • In early 2015, Merck & Co.'s drug Keytruda has been approved to treat melanoma, a type of skin cancer. Keytruda's FDA approval as a lung cancer treatment was announced on Oct. 2, 2015.
  • Also known as 'pembrolizumab', Keytruda is designed for patients with advanced non-small cell lung cancer (NSCLC). Patients who suffer from the illness have tumors with a specific protein called 'programmed cell death protein 1' or PD-L1.
  •  Keytruda contains an antibody which targets another protein called PD-1. When PD-L1 and PD-1 bind together, PD-1 lowers T lymphocytes or T-cells in the immune system. 
  • Normal levels of T-cells help the body fight cancer cells. Evidently low levels of T-cells are prominent in HIV/AIDS patients.
  • By blocking the interaction between proteins PD-L1 and PD-1 in the molecular pathway, Keytruda could help the immune system to fight off cancer cells.
  • An accompanying diagnostic, the PD-L1 IHC 22C3 pharmDx test, has also been approved by the FDA. This is the first diagnostic test to detect PD-L1 proteins in lung cancer patients.

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