Let's start with Xalkori
– I have already
written that ALK-mutation is the key to success of the
treatment... And what should do those who do not have this kind of
mutation? And... guess what? According
to the germans Xalkori does not work well even for those who do
hav this mutation!!!
Germany's
Institute for Quality and Efficiency in Health Care (IQWiG) said in a
preliminary benefit assessment that Xalkori crizotinib from Pfizer
Inc. (NYSE:PFE) provides "no additional benefit" over
docetaxel or pemetrexed-containing chemotherapy in patients with
previously treated, advanced non-small cell lung cancer (NSCLC) whose
tumors are anaplastic lymphoma kinase (ALK)-positive -- Xalkori's
approved indication. IQWiG said Xalkori may lead to improvements in
health-related quality of life vs. the comparators requested by
Germany's Federal Joint Committee (G-BA) in patients for whom
chemotherapy is still an option. However, IQWIG said patients
receiving Xalkori were at an increased risk for serious adverse
events.
Because
Pfizer's dossier did not include the requested data, IQWiG said
Xalkori also has "no additional benefit" over G-BA's
requested comparator of best supportive care (BSC) in patients for
whom chemotherapy is no longer an option.
And
the second failure is ABT-199,
and not only this very targeted drug but other several candidates! It
is a disaster for the company – to invest a huge amount of
resources and time and then fail...
AbbVie
Inc., the drug company that split off from Abbott Laboratories at the
start of the year, suspended five studies on its experimental
leukemia and lymphoma medicine after two patient deaths.
The
patients died from tumor lysis syndrome, said Tracy Sorrentino, a
spokeswoman for North Chicago, Illinois-based AbbVie. The
complication stems from the rapid destruction of malignant cells
after treatment that can trigger acute kidney failure. It occurs most
often with large tumors such as those found in leukemia and lymphoma
patients, according to the National Institutes of Health.
ABT-199
is one of the company’s most-promising new compounds and was slated
to start the final round of testing usually required for U.S.
regulatory approval this year.
“We
have every expectation that these trials will come off the partial
clinical hold and we’ll be able to initiate Phase 3 trials in 2013
as planned,” she said. “ABT-199 is a highly- potent agent and can
result in the tumors reducing really quickly,” she said. “We are
working to refine the dose.”
After the complication was discovered, AbbVie and its partner, Roche Holding AG, suspended the dose-escalation portion of the studies to determine the amount of drug that is safest and most effective, Sorrentino said. The risk stems from the drug’s potency and can be managed if the dose is carefully controlled, she said.
You seriously miss the point about Xalkori. 60% of patients getting the drug at the metastatic state lived 12 months longer than the control group. That is hardly 'no effect'. The Germans don't like the fact that the patients still die after a year. So, what the Germans should have said is chemo kills patients faster and a whole lot cheaper than Xalkori. That is what this decision was based upon.
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