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 The European Commission approved Alecensa as a treatment for a
mutated form of lung cancer called ALK-positive, the company said on
Thursday, while U.S. regulators backed Perjeta for use in certain
early-stage breast cancer patients after surgery.
The EU decision had been expected following a positive
recommendation in October from experts, after evidence showed
patients taking the targeted lung cancer drug had a lower risk of
disease progression or death than those on Pfizer's rival product
Xalkori.
The U.S. green light for Perjeta in combination with Herceptin and
chemotherapy for treating HER2-positive early breast cancer after
surgery follows a clinical trial that demonstrated a modest benefit.
That trial had disappointed investors when results were announced in
June, but Roche had continued to express confidence in the
medicine's prospects.
Analysts at Jefferies said U.S. Food and Drug Administration's (FDA)
approval for expanded Perjeta use came about a month earlier than
anticipated and the stipulations around its use were better than
expected.
Based on a survey of oncologists, Jefferies expects U.S. cancer
doctors to use Perjeta in 44 percent of post-surgery, or adjuvant,
patients currently treated with Herceptin, which translates into a
revenue opportunity of around $4.3 billion.
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The FDA also granted full approval of the Perjeta-based regimen in
pre-surgery, or neoadjuvant, treatment, which Jefferies said could
add more than $1 billion.
Roche is at a critical juncture, after years of strong sales growth,
because its older cancer drugs are about to face competition from
cheaper so-called biosimilar versions.
Chief Executive Severin Schwan told Reuters this month the impact
from biosimilars would be significant but that the pipeline of new
products had been "de-risked", enabling the company to compensate
for this erosion.
(Reporting by Brenna Hughes Neghaiwi and Ben Hirschler; Editing by
Edmund Blair
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