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By Carl O'Donnell
April 29 (Reuters) - The U.S. Food and Drug Administration
on Wednesday cleared expanded use of GlaxoSmithKline Plc's
Zejula as a first option to keep advanced ovarian cancer
at bay in women who have responded to chemotherapy.
The approval, which does not limit the drug to women with
certain genetic anomalies, should open up Zejula to expanded use
in a larger patient population and could signal a similar
opportunity for other drugs in the same class, known as PARP
inhibitors.
PARP inhibitors work by blocking enzymes involved in
repairing damaged DNA, thereby helping to kill cancer cells.
They are a growing focus for drug research, with potential for
use in breast, lung and prostate cancers.
Zejula is the first PARP inhibitor cleared for use on its
own as a first-line maintenance therapy for ovarian cancer
patients who do not have a mutation of the BRCA enzyme, which
occurs in about 20% of women with ovarian cancer.
Maintenance therapy - meaning it is used to help keep cancer
from recurring - can significantly boost sales because the drug
is typically used for a longer duration.
The FDA nod will help Zejula better compete with rival PARP
inhibitors, which include AstraZeneca and Merck & Co's
Lynparza and Clovis Oncology's Rubraca.
Zejula was previously approved for use as a maintenance
therapy in patients who had recurrent bouts of ovarian cancer
and as a treatment for patients with specific genetic mutations
who had previously been given multiple rounds of chemotherapy.
As first-line maintenance, it can now be used earlier in the
course of the disease for patients who have responded to
chemotherapy.
Wednesday's approval marks a win for GSK's deal-making
strategy. It acquired Zejula with its 2019 purchase of drugmaker
Tesaro Inc for $5.1 billion, at a time when investors were
growing skeptical about the potential of its flagship drug.
"We are very excited," said GSK research head and chief
scientific officer Hal Barron. "We said at the time we acquired
Tesaro that the PARP class was significantly underappreciated."
Under Chief Executive Emma Walmsley, the London-based
drugmaker has sold several assets, and bought others in
fast-growing markets such as oncology, to try to rejuvenate
growth as several of its older drugs face the loss of patent
protection.
On Wednesday, GSK's first-quarter profit beat analysts’
expectations due to strong demand for its blockbuster shingles
vaccine and higher sales of some of its pain relief medicines
during the coronavirus pandemic.
(Reporting by Carl O'Donnell
Editing by Bill Berkrot)
