f*******o
发帖数: 26 | 1 J&J, AbbVie's Imbruvica breaks into larger CLL market with first-line FDA
nod
March 4, 2016
Johnson & Johnson and AbbVie have snagged the indication for standout cancer
med Imbruvica that they've been waiting for.
On Friday, the FDA granted the pair a first-line nod in chronic lymphocytic
leukemia (CLL) based on results of a Phase III trial in which the med cut
the risk of disease progression or death by 84% compared with chemo
treatment chlorambucil.
It's a win for the companies, which already had indications for Imbruvica in
previously treated CLL patients, as well as those with previously treated
mantle cell lymphoma and those with Waldenström macroglobulinemia. And
the companies are hoping the list won't end there, with an eye on
potentially expanding into other B-cell malignancies like multiple myeloma.
But AbbVie, for one, expects nearly a third of Imbruvica's forthcoming
growth to come from moving into earlier lines of therapy the way it'll now
be able to do in CLL. First-line label expansions bring along larger groups
of patients who stay on treatments for longer periods of time; in the U.S.,
15,000 new CLL patients are diagnosed every year, the companies said in a
statement.
And AbbVie was counting on that potential when it agreed last year to shell
out $21 billion to buy J&J partner Pharmacyclics--a sum analysts pegged as "
lofty," "staggering," and even "astronomical." The Illinois pharma predicts
the med will be able to haul in at least $7 billion for the company at its
peak, a number that calculates out to about $11.5 billion to $12 billion in
end-user sales, Evercore ISI analyst Mark Schoenebaum has projected. | f*******o
发帖数: 26 | 2 A puzzling UK rejection on Imbruvica for CLL
Thu, 03/03/2016
Johnson & Johnson (J&J) received a rejection from the United Kingdom's
National Institute of Care and Excellence (NICE) regarding its new leukemia
drug Imbruvica.
NICE's job is to decide which drugs should be covered under health insurance
plans in England and Wales. Draft guidance issued by the agency said it
wasn't confident Imbruvica "represented an effective use of resources,"
according to Reuters. It has a list price of $78,000 a year or 55,954.50
pounds
Imbruvica has shown promise in treating three different types of blood
cancer, but NICE felt this medication wasn't a viable treatment option for
chronic lymphocytic leukemia (CLL) patients who would not be good candidates
for chemo-immunotherapy.
J&J's European supplier Janssen released a statement expressing their dismay
at this decision. The company was "extremely disappointed" because 48
countries have accepted the drug under the CLL indication.
Janssen said it will work with NICE to find a way to ensure patients
continue to have access to Imbruvica. FiercePharma elaborated that Imbruvica
is a top-seller for Janssen. It brought in $235 million in the fourth
quarter of 2015 versus $92 million in the previous year.
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【在 f*******o 的大作中提到】
: J&J, AbbVie's Imbruvica breaks into larger CLL market with first-line FDA
: nod
: March 4, 2016
: Johnson & Johnson and AbbVie have snagged the indication for standout cancer
: med Imbruvica that they've been waiting for.
: On Friday, the FDA granted the pair a first-line nod in chronic lymphocytic
: leukemia (CLL) based on results of a Phase III trial in which the med cut
: the risk of disease progression or death by 84% compared with chemo
: treatment chlorambucil.
: It's a win for the companies, which already had indications for Imbruvica in
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