ORENCIA TO GET BLACK-BOX WARNING FOR LUNG CANCER

Heard from an Orencia investigator in N.C., FDA is deciding to pull the drug or give it the worst black box warning ever in the history of black box warnings.

Stay tuned folks. It is going to be a wild ride. Should have stayed at my old company. But what the hell, they are paying me a mint.

 

You are a lying idiot with no morals. How dare you spread total nonsense like this - this is a criminal act you are commiting. You should be ashamed of yourself. Please stay off this site in future.

 

[ QUOTE ]
Heard from an Orencia investigator in N.C., FDA is deciding to pull the drug or give it the worst black box warning ever in the history of black box warnings.

Stay tuned folks. It is going to be a wild ride. Should have stayed at my old company. But what the hell, they are paying me a mint.

[/ QUOTE ]

OK, wise guy. What in the world are you talking about? Care to create a reason why this might happen? What data set would you be referring to? You're a crock.

 

[ QUOTE ]
Heard from an Orencia investigator in N.C., FDA is deciding to pull the drug or give it the worst black box warning ever in the history of black box warnings.

Stay tuned folks. It is going to be a wild ride. Should have stayed at my old company. But what the hell, they are paying me a mint.

[/ QUOTE ]

Yeah right! Nice try competitor. Sit back and spend your time starting rumors on cafe pharma while we eat your lunch.

 

Re: ORENCIA TO GET BLACK-BOX WARNING FOR LUNG CANCER [Re: Anonymous]
#1413155 - 05/29/06 11:16 PM Edit Reply Quote Quick Reply



You are a lying idiot with no morals. How dare you spread total nonsense like this - this is a criminal act you are commiting. You should be ashamed of yourself. Please stay off this site in future.

Post Extras:


When did it become unlawful to post crap on CP? The whole website is crap!

 

8 cases of lung cancer in original submission to FDA

4 more cases reported to FDA since launch

12 cases total

Do I smell "Voluntary Withdrawal of Orencia until further investigation"??????

 

Umm, if the drug was that quickly carcinogenic, wouldn't it be causing some other types of cancer in other parts of the body???? How quickly are these cancers supposed to be developing?

 

[ QUOTE ]
8 cases of lung cancer in original submission to FDA

4 more cases reported to FDA since launch

12 cases total

Do I smell "Voluntary Withdrawal of Orencia until further investigation"??????

[/ QUOTE ]

1) Even IF your data is correct, I ask you - 12 cases of cancer out of how many total patients? Then, what is this percentage? OK, now that you have this percentage, how does it compare to the general population's, or the RA population's, spontaneous Ca rate? Hint: you'd have to have more than the expected spontaneous rate to raise eyebrows.

2) What data are you referring to, anyway? Orencia FDA submission package for approval? Nice try. Even an FOI request for the SBA couldn't have released that data that fast. And since that's not any kind of data that BMS would voluntarily publish, then I have to call bullshit on you. Unless, of course, you have inside information, which is highly unlikely.

3) The recently-released Ca data on Remicade and Humira has been at the FDA for some time. Do you really think that if Orencia had even the slightest hint of carcinogenicity that a) BMS would have rushed it out, or b) FDA would have approved it at all, much less on the fast-track time line that it did?

OK, I've wasted enough brain cells on you. Nice try to stir up the mud here. Nighty night and move on to another site.

 

FROM THE FDA WEBSITE: hmmmmmmmm

"FDA may also ask the committee to address the potential for increased risk of malignancy with abatacept. Immunosuppressant drugs are known to be associated with increased risk of malignancy, the agency notes.

“Although the number of overall malignancies was less than expected, there was a higher incidence of lung cancer and lymphoma compared to that expected,” the briefing document states.

The agency appears most concerned about the potential lung cancer risk. In clinical trials, eight abatacept patients were diagnosed with lung cancer.

FDA used a database analysis to establish a background rate of lung cancer incidence for RA patients. Based upon the database analysis, the agency determined that abatacept’s lung cancer rate was twice that of the normal RA population."

 

what you just sited was on the FDA website BEFORE the drug was approved. If that was the case, why would the FDA approve it. with any biologic, you increase your chances of infection. even w/ humira and remicade. if the whole 'lung cancer' thing was such an issue, neither the company nor the FDA would have allowed orencia to come to the market.

there's no way it's going to be pulled.

 

[ QUOTE ]
FROM THE FDA WEBSITE: hmmmmmmmm

"FDA may also ask the committee to address the potential for increased risk of malignancy with abatacept. Immunosuppressant drugs are known to be associated with increased risk of malignancy, the agency notes.

“Although the number of overall malignancies was less than expected, there was a higher incidence of lung cancer and lymphoma compared to that expected,” the briefing document states.

The agency appears most concerned about the potential lung cancer risk. In clinical trials, eight abatacept patients were diagnosed with lung cancer.

FDA used a database analysis to establish a background rate of lung cancer incidence for RA patients. Based upon the database analysis, the agency determined that abatacept’s lung cancer rate was twice that of the normal RA population."

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This is news to me, and I haven't found it from searhcing the FDA website. Can you tell me where this is or paste a link?

 

If there have been cases of cancer, I doubt it'll get pulled off the market. Read the side effects of Humira.

 

"4 new cases reported post approval by investigation sites" - approximately N= @2,500 study patients - That's a 50% increase in Lca in 4 months - This is real folks, confirmed with another investigator who attended Chicago meeting in May. "Rate is > 2x RA population" Likely NOT pulled, but CA Warning specific to Orencia guaranteed - FDA pulling group of top Rheums together for an 'experts consultancy' similiar to the Tysabri evaluation over at buyogen - Not waiting for the axe on this one - just got calls for opportunities with Roche - nephrology & schering oncology. check it out. [ QUOTE ]
what you just sited was on the FDA website BEFORE the drug was approved. If that was the case, why would the FDA approve it. with any biologic, you increase your chances of infection. even w/ humira and remicade. if the whole 'lung cancer' thing was such an issue, neither the company nor the FDA would have allowed orencia to come to the market.

there's no way it's going to be pulled.

[/ QUOTE ]

 

[ QUOTE ]
"4 new cases reported post approval by investigation sites" - approximately N= @2,500 study patients - That's a 50% increase in Lca in 4 months - This is real folks, confirmed with another investigator who attended Chicago meeting in May. "Rate is > 2x RA population" Likely NOT pulled, but CA Warning specific to Orencia guaranteed - FDA pulling group of top Rheums together for an 'experts consultancy' similiar to the Tysabri evaluation over at buyogen - Not waiting for the axe on this one - just got calls for opportunities with Roche - nephrology & schering oncology. check it out. [ QUOTE ]
what you just sited was on the FDA website BEFORE the drug was approved. If that was the case, why would the FDA approve it. with any biologic, you increase your chances of infection. even w/ humira and remicade. if the whole 'lung cancer' thing was such an issue, neither the company nor the FDA would have allowed orencia to come to the market.

there's no way it's going to be pulled.

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References and/or links, please. You're quoting somebody and referring to the FDA. Time to put up the link.

 

See? That guy was talking trash. No links. No references.

No problem.

 

ASK YOUR BOSS IF 4 NEW LC CASES WERE REPORTED TO THE FDA FROM TRIAL SITES SINCE LAUNCH. THEY WOULDN'T LIE TO YOU, WOULD THEY? OR ARE YOU AFRAID TO KNOW THE TRUTH...TICK, TICK, TICK

 

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ASK YOUR BOSS IF 4 NEW LC CASES WERE REPORTED TO THE FDA FROM TRIAL SITES SINCE LAUNCH. THEY WOULDN'T LIE TO YOU, WOULD THEY? OR ARE YOU AFRAID TO KNOW THE TRUTH...TICK, TICK, TICK

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Is that the sound of your shaking in your boots, Mr. competitor?

 

Seriously, If you are really a BMS Orencia Rep, will you call your manager/MSL and ask them that question for all of us and then report back here? You have the power to dispell the whole thing... Will you?...If you don't report back here, we'll assume there will soon be a 120-day safety update with 12 LC's. You really should find out.

 

It's your 120 Day safety update - FDA requirement - It was discussed at an investigators meeting because the informed consent is changing for study patients and investigators are the first to know. Eular should be a tough one for you this year as well...Seen your abstracts? Boy, you all did hire the best and brightest, didn't you... [ QUOTE ]
See? That guy was talking trash. No links. No references.

No problem.

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you are a rocket scientist

google abatacept and lung cancer

or won't bms let you use your computer?