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Merck takes on Roche with first-line bladder OK for Keytruda

FDA awards accelerated approval for mUC patients

Merck & CoMerck & Co's Keytruda has joined the throng of immuno-oncology drugs cleared in the US for bladder cancer, picking up first- and second-line approvals from the FDA.

Keytruda (pembrolizumab) has been given accelerated approval as a first-line therapy for metastatic urothelial carcinoma (mUC) patients who are ineligible for cisplatin-based chemotherapy at the outset, as well as for patients who have progressed within 12 months of chemotherapy.

Merck says the PD-1 inhibitor is the only drug in the class to have shown a survival advantage compared to chemotherapy in US patients who have progressed despite cisplatin chemotherapy.

Keytruda joins Roche's Tecentriq (atezolizumab) in the first-line UC treatment setting, and Tecentriq and three other checkpoint inhibitors - Bristol-Myers Squibb's Opdivo (nivolumab), Merck KGaA/Pfizer's Bavencio (avelumab), AstraZeneca's Imfinzi (durvalumab) - have approval as second-line therapies for the cancer.

Cancer immunotherapies have transformed the treatment of UC - the most common form of bladder cancer - after decades in which chemotherapy was the only option for patients. Just which of the new PD-1/PD-L1 inhibitor class wins out in the marketing clash remains to be seen. Roche took an early lead with Tecentriq's accelerated approval last year, but suffered a setback this month when a trial intended to confirm its efficacy failed to meet its targets.

That prompted analysts at Evercore to ask whether there might be a more general issue with checkpoint inhibitors used as monotherapy in bladder cancer, which could be exposed as other confirmatory trials come through. As it stands all the checkpoint inhibitors have been approved on the back of phase II trial data.

Meanwhile BMS's torrid experience with Opdivo in first-line NSCLC and AZ's pleasant surprise for Imfinzi in that indication show that there are no guarantees in the cancer immunotherapy field.

For Merck the new FDA approvals continue to build an extensive set of indications for Keytruda, which just this month also picked up new indications in first-line combination therapy for non-small cell lung cancer (NSCLC) and classical Hodgkin's lymphoma. The drug made $1.4bn for Merck last year, adding another $584m to that tally in the first three months of this year.

It has been estimated that approval for bladder cancer could add another $1bn in peak sales potential for the drug - assuming Merck's confirmatory trial comes good.

Article by
Phil Taylor

19th May 2017

From: Sales

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