FDA accepts new Keytruda data, opening door for wider indication
- FDA will review new data on Merck's anti-PD-1 cancer drug Keytruda, opening the door for a wider indication, the company said earlier this week. The new data supports Keytruda's indication for metastatic non-small cell lung cancer (NSCLC).
- Merck won accelerated approval for NSCLC in October 2015, conditional on confirmatory clinical trials—which the drugmaker has now submitted with its supplemental Biologics License Application.
- In the phase 2/3 Keynote-010 trial, Keytruda demonstrated a 29% improvement in overall survival at low dosage and a 39% improvement at a higher dose compared to the standard chemotherapy (docetaxel).
Keytruda and Bristol-Myers Squibb's Opdivo are locked in a struggle for supremacy in the anti-PD1 space. Merck beat BMS to regulatory approval by three months with Keytruda's second-line indication for metastatic melanoma in September 2014. But Opdivo quickly made up ground, winning the same indication and then another for second-line treatment of NSCLC significantly before Keytruda.
As Opdivo has won new approvals, analysts have upped sales forecasts. Consensus expectations put annual sales for Opdivo at $11.1 billion by 2020, according to a Reuters report from February. Keytruda's forecasts are around half that.
This has been borne out on the ground as well. BMY pulled in $942 million from Opdivo sales in 2015, with more than half ($475 million) coming in the fourth quarter alone. This laps Keytruda's $566 million in 2015 sales ($214 in Q4).
Currently indicated for second-line treatment of metastatic NSCLC with PD-L1 expression as determined by an FDA-approved diagnostic, Keytruda could see a wider indication following the recent submission with Keynote-010 data.
The drug recently got a significant PR boost when former President Jimmy Carter announced he no longer needs cancer treatment. Only seven months ago, Carter revealed he had been diagnosed with melanoma which had already spread into his brain. After several months of treatment with Keytruda however, scans of his brain showed no signs of cancer.
Keytruda is also used more often than Opdivo in combination studies pairing it with another drug. According to data from EP Vantage, there are over 50 combo studies using Keytruda compared to 40 for Opdivo. Many of those studies pair Keytruda with a small molecule or chemotherapy.
Merck is also submitting a Marketing Authorization Approval to the European Medicines Association in order to update Keytruda's label in the E.U. markets.
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