MSD’s Keytruda given first FDA approval for first line treatment
pharmafile | October 25, 2016 | News story | Manufacturing and Production | BMS, MSD, NSCLC, keytruda, opdivo
MSD, known as Merck in the US, has scored a big success in treating non-small cell lung cancer (NSCLC), with the FDA approving Keytruda for first-line treatment for the first time. This means that Keytruda will be the first treatment for patients with metastatic NSCLC with high-levels of the protein, PD-L1, that is known for suppressing the immune system.
The treatment will then be approached initially instead of the current treatment method of beginning with chemotherapy. To add to the good news for MSD, the FDA approved a Keytruda labelling update for second-line treatment for certain patients, reflecting favourable data from the Keynote-010 trial.
The approval is based on data from the Phase III trial, KEYNOTE-024, which found that Keytruda reduced the risk of death by 40% and improved progression-free survival (PFS) by 4.3 months compared with doublet chemotherapy for untreated patients with advanced NSCLC with PD-L1 expression on at least 50% of cells. This is the same indication that Bristol-Myers Squibb had attempted to push their drug Opdivo towards, only for it to fail in their Phase III trial.
This update is the latest twist in the hugely competitive field for NSCLC treatment. The approval by the FDA will see a number of patients beginning to take Keytruda, boosting their current position against Opdivo that is still reeling from their indication failure.
“Keytruda improved survival, compared to traditional chemotherapy, in patients with non-small cell lung cancer whose tumours express high levels of PD-L1,” said Roger M. Perlmutter, president, Merck Research Laboratories. “The approval of Keytruda for the first-line treatment of metastatic non-small cell lung cancer has the potential to change the treatment landscape for these patients.”
Ben Hargreaves
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