By Bhanvi Satija and Christy Santhosh
Aug 20 (Reuters) -
The U.S. health regulator on Tuesday approved Johnson &
Johnson's ( JNJ ) chemotherapy-free combination treatment for a
type of non-small cell lung cancer, giving patients access to a
therapy that could replace the current standard of care.
The approval allows the use of J&J's cancer drug,
Rybrevant, in combination with an older drug, lazertinib, as a
first-line treatment for non-small cell lung cancer (NSCLC)
patients with a mutated form of a gene called EGFR.
NSCLC is the most common type of lung cancer, and the EGFR
mutation occurs in 10-15% of the cases in the United States,
according to data from the American Lung Association.
The Food and Drug Administration's decision is based on data
from a late-stage study, in which J&J's Rybrevant combination
increased the time patients lived without their disease
worsening, compared with AstraZeneca's ( AZN ) blockbuster drug,
Tagrisso.
Tagrisso is commonly used as a front-line treatment for
NSCLC patients, followed by chemotherapy.
J&J's Rybrevant is already approved for the treatment of
NSCLC as a monotherapy and in combination with chemotherapy for
patients with the EGFR mutation in the United States.
The company expects Rybrevant, which is among its newer
cancer treatments, to generate more than $5 billion in peak
sales.
Rybrevant disrupts growth of EGFR and another gene
called MET to slow down or stop the spread of tumorous cells,
while lazertinib inhibits their rapid reproduction.
The company will be ready to launch the combination "any
second" after the FDA's decision and is making arrangements that
will support the launch, said Biljana Naumovic, a J&J executive
who oversees the commercial strategy for the drugmaker's
oncology treatments.
"We are the first chemo-free therapy that comes in the
frontline setting, in the space where we want to bring more
survival and more life for the patients and around the world."