Merck's Keytruda cancer drug has got the nod of U.S. regulators in treating certain forms of lung cancer as a first-line cure. Thanks to the clearance from the FDA, the drug is now eligible for treating patients suffering from metastatic non-small cell lung cancer.
The NSCLC is conspicuous with tumors having levels of protein PD-L1 without EGFR aberrations or ALK genomic tumors.
For Merck, the FDA approval has opened up a huge market where almost a quarter of non-small cell lung cancer patients are battling tumors and PD-L1 expressions.
Welcoming the FDA nod, Roger Perlmutter, president of Merck Research Laboratories said first-line approval of the drug "has the potential to change the treatment landscape for these patients."
The drug is already available on the U.S. market for treating metastatic NSCLC, melanoma and neck cancer.
In curing lung cancers, Keytruda plays the role of a humanized monoclonal antibody, elevating the immune system ability to fight tumor cells by activating T lymphocytes.
Keytruda monotherapy's success rate in progression-free survival was noted when compared to chemotherapy. It has the track record in curbing progression risk and death by an average 40 percent.
Options Beyond Chemotherapy
"Patients now have an option beyond chemotherapy at initial diagnosis. This approval reinforces the need for biomarker testing so care can be personalized and most effective," noted Laurie Fenton Ambrose, president and chief executive of the Lung Cancer Alliance.
Now FDA has a target date of Dec. 24 for the drug's new use. According to market estimates, the annual sales of the drug may zoom to $8.1 billion by 2021.
Leerink analyst Seamus Fernandez also said the FDA nod would bolster Merck's leadership in the first-line lung cancer market for the coming years before new combination therapies take center stage.
Though rival Bristol-Myers Squibb's drug Opdivo was in the race for FDA approval, it lost out at the final stage.
Already Keytruda, Opdivo and Tecentriq are competing in the lung cancer market for the niche of post-chemotherapy applications.
Among cancers, lung cancer is the world's biggest killer with an annual toll of 1.6 million and that makes it a bigger market.
Immunotherapy drugs also have a wider usage as in cancers of the bladder, kidney, head and neck besides melanoma, and Hodgkin lymphoma.
The positive data from KEYNOTE-024 study strengthened the approval process and showed Keytruda's stride in having improved survival rate of patients with high PD-L1, unlike chemotherapy.
Merck is testing Keytruda for than 30 cancers and collaborating with companies such as Amgen, Incyte, GlaxoSmithKline and Pfizer for the evaluation of Keytruda in other areas.
