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 The green light from the Food and Drug Administration (FDA),
announced by the U.S. drugmaker late on Monday, confirms Merck's
leading position in the hot area of medicines that fight tumors by
harnessing the body's immune system.
Keytruda's latest approval is for treating first-line metastatic
non-small cell lung cancer (NSCLC) in patients with high-levels of a
protein called PD-L1, which makes them more receptive to
immunotherapy.
The FDA had set a target date of Dec. 24 for deciding on this new
use.
Expectations for Keytruda, which works by taking the brakes off the
immune system, have been building since its success in treating
selected untreated patients. Annual sales of the drug are now
expected to reach $8.1 billion in 2021, according to consensus
forecasts compiled by Thomson Reuters.
Rival Bristol-Myers Squibb's drug Opdivo failed in a late-stage
trial for the same indication. Bristol had tried to make Opdivo work
irrespective of PD-L1 levels. In the event, it disappointed
comprehensively in a major study.
Keytruda and Opdivo, along with Roche's rival immunotherapy
Tecentriq, are already approved for lung cancer patients who have
undergone previous chemotherapy.
Keytruda had originally only been cleared in this second-line
setting for patients with high PD-L1 levels but the FDA also
expanded this on Monday to allow for treatment where PD-L1
expression is just 1 percent or more.
Immunotherapy drugs are used additionally in melanoma, Hodgkin
lymphoma and cancers of the bladder, kidney, head and neck, but lung
cancer, the world's biggest cancer killer with an annual death toll
of 1.6 million, is the biggest potential market.
Although doctors are allowed to prescribe medicines for not yet
approved uses, the FDA's first-line clearance of Keytruda could
greatly increase the number of patients taking the drug.
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Leerink analyst Seamus Fernandez said the news should cement Merck's
position as leader in the first-line lung cancer field for at least
the next 12 to 18 months, after when the battle is likely to shift
to new combination therapies.
Only a quarter to a third of non-small cell lung cancer patients
have tumors with at least 50 percent of cells producing PD-L1,
making them suitable for first-line Keytruda, so around 70 percent
of the market is still up for grabs.
As a result, the race is now on between Merck, Bristol, Roche and
AstraZeneca to find smart ways for combining treatments, either by
adding chemotherapy or using two different immunotherapies in
tandem.
Merck's first-line approval was based on data from a late-stage
study which showed Keytruda achieved superior progression-free and
overall survival compared to chemotherapy in patients whose tumors
expressed high levels of PD-L1.
(Editing by Lisa Shumaker and Jane Merriman)
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