Posted by : Pradnya Savekar
On : 13 January 2015
Comments : 1
Views : 2486
Merck predicts an earlier than expected expansion of Keytruda, the company's newly approved cancer immunotherapy be a block buster for the new year. Already launched melanoma, which could win FDA's approval later this year in non-small cell lung cancer, as per the predictions.
Keytruda won the agency's brekthrough therapy designation for NSCLC in october 2014, a sing that Merck has data that's ahead of the pack.Merck's phase I trial on Keystone-001,which looked at Keytruda in both melonoma and NSCLC (non small cell lung carcinoma).
Another important thing about Keytruda inNSCLC is; the Bristol-Mayer's Squibb is on the way to win Lung canncer aproval for its rival drug, Opdivo, before Keytruda does according to the Research Analyst Tim Anderson. But that first-to-market status may not deliver as much for Bristol-Mayers as one might have predicted. Merck's rug is in line for broad approval, as a second line therapy in both squamous and non-squamous NSCLC , wherein Opdivo is most likely looking at third line therapy in the squamous NSCLC cases only. Non-squamous disease accounts for about 75% of NSCLC cases, and according to the past record only about 25% to 30% of patients who fail on second-line therapy move to third-line options.
Thus, the research analyst Anderson predicts that Merck's Keytruda would outperform with the sales forecast for the product is about $900 million in 2015, compared with a consunsus estimate of $410 million, and boosting his sales expectations to $3.7 billion, compared with the agreementof $3.1 billion.
If a couple of Bristol-Mayer's ongoing trials stop early, Opdivo could win second line approval in both types of NSCLC can potentially hamper Keytruda. And then there's Roche, which might actually file its PD-L1 drug for approval in NSCLC this year, who is also implementing similar stratergy to Merck's "stealth" approach.
However, immuno-oncology is looking to be the biggest pharma stories of the year.Keytruda and Opdivo are up for a head-to-head fight in melanoma alredy, and Roche and AstraZeneca are working to advance thrie own entries.