FDA Give Early OK to Merck’s Keytruda for in first-line lung cancer treatment

fda_logoKeytruda has become the first drug in the PD-1/PD-L1 inhibitor class to be approved for first-line treatment of non-small cell lung cancer (NSCLC), enabling acceleration in its use.

The US FDA approved Merck’s drug two months ahead of schedule for patients with advanced NSCLC whose tumours express high levels of PD-L1.

In the KEYNOTE-024 trial, Keytruda improved both progression-free survival and overall survival when compared to platinum-based chemotherapy in the patients.

The green light provides Merck with another opportunity to gain ground on its arch-rival BMS, whose PD-1 inhibitor Opdivo is currently outselling Keytruda by a factor of three. In the first six months of the year sales of Opdivo came in at $1.54bn, with Keytruda bringing in $563m.

Keytruda, Opdivo and Roche’s new PD-L1 inhibitor Tecentriq are all approved for second-line treatment after chemotherapy in NSCLC patients, but claiming the first-line indication is expected to be crucial for future dominance in the big NSCLC market.

Roche is also testing Tecentriq in combination with chemotherapy in NSCLC patients with high and low PD-L1 expression levels, while BMS is hoping that an all-comer trial looking at the combination of its two current immuno-oncology drugs – Opdivo and CTLA4 inhibitor Yervoy – could tip the balance in its favour once again.

Merck will make gin the meantime, and with PD-L1 testing becoming more common in the first-line setting there could be a pull-through effect for Keytruda into second-line treatment, further lessening Opdivo’s advantage in this form of cancer.

Keytruda’s competitive position in second-line has also been improved by another FDA approval, this time for labelling that will make patients who have failed to improve with chemotherapy eligible for pembrolizumab even if their tumours produce a low level of PD-L1.


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