Merck & Co have applied to the FDA for approval to combine their immunotherapy drug, Keytruda, with chemotherapy as an initial treatment for advanced lung cancer. The FDA agreed to expedite the case, and give the application a much faster review.
Merck released a statement saying the U.S. Food and Drug Administration (FDA) would reach a decision by May 10 of this year. That announcement alone was enough to send the drug manufacturer’s shares more than 3% higher.
This is an important issue in the cancer market, as Merck is not the only drug manufacturing company that are pursuing combination regimens of their own.
Merck’s primary treatment drug for lung cancer, Keytruda, has already been approved as an initial treatment for advanced lung cancer in patients whose tumours have a high level of PD-L1 expression, the protein that the drug targets to help the immune system fight cancer.
This first application for Keytruda in combination with another medicine would include patients with metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression level, opening up a much larger market for the medicine.
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