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 The drug, rubraca, which secured approval about two months earlier
than scheduled, targets patients whose tumors have a mutation called
BRCA, identifiable using an FDA-approved companion diagnostic test.
When a drugmaker wins accelerated approval, it must provide further
evidence of the drug's benefit, failing which the approval can be
revoked.
The FDA also approved on Monday a test made by Foundation Medicine
Inc to help detect the presence of BRCA mutations. If one or more
mutations are detected, the patient is eligible for rubraca.
About 15-20 percent of ovarian cancer patients have the BRCA
mutation, the FDA said.
Rubraca is expected to compete against Tesaro Inc's niraparib and
AstraZeneca Plc's lynparza. Tesaro applied for U.S. marketing last
month after data released in October showed niraparib improved
outcomes for all women with recurrent ovarian cancer.
All three drugs belong to a closely watched class of new medicines
called PARP inhibitors, which block enzymes involved in repairing
damaged DNA, thereby helping to kill cancer cells.
Lynparza became the first of the new class of drugs to reach the
market when it won U.S. approval for ovarian cancer in 2014. The
drug generated sales of $156 million in the first nine months of
this year.
With a broader label than lynparza, Clovis now has the opportunity
to establish a larger foothold ahead of competitive entrants in the
maintenance setting, Piper Jaffray's Joshua Schimmer said in a note.
Maintenance therapy immediately follows initial treatment to keep
patients cancer-free if they go into remission.
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Niraparib and lynparza are both positioned to enter the maintenance
setting ahead of rubraca, and how the competitive dynamic evolves
remains to be seen, Schimmer said.
Rubraca is expected to generate sales of $267 million in 2018,
according to brokerage Janney Montgomery Scott.
Other drugmakers, including AbbVie and Medivation, which was
recently bought by Pfizer Inc for $14 billion, also have PARP
inhibitors in development.
Clovis's shares doubled in late-September, after the company said
rubraca would be reviewed on a priority basis, and the FDA would
make its decision by Feb. 23.
Clovis's shares soared as much as 26 percent to $46.97 after trading
resumed. Tesaro's shares fell about 4 percent to $126.07.
(Reporting by Divya Grover in Bengaluru; Editing by Martina D'Couto
and Sriraj Kalluvila)
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