FDA panel set to review Pfizer and Novartis pancreatic neuroendocrine cancer drugs

“U.S. regulators questioned data from Pfizer Inc. and Novartis AG on two potential therapies for a rare form of pancreatic cancer with limited treatment options, documents showed on Friday,” Esha Dey and Lisa Richwine report for Reuters.

“The companies are seeking approval to promote already approved cancer medicines for treating advanced pancreatic neuroendocrine tumors, an uncommon type of cancer that has afflicted Apple Inc. Chief Executive Steve Jobs,” Dey and Richwine report. “Food and Drug Administration staff, in a preliminary analysis, said Pfizer’s decision to end a study of the drug Sutent early may have led to an overestimation of its effectiveness. Agency reviewers also raised issues with Novartis’ findings on the benefits of its drug, Afinitor… Pfizer’s Sutent study was terminated well before a scheduled interim analysis that required 130 events of patients living without their disease progressing, FDA reviewers said.”

Dey and Richwine report, “Pfizer said the Sutent study was stopped early based on a recommendation from an independent data monitoring committee. The recommendation was based on prolonged progression-free survival reported in patients getting Sutent compared with a higher number of deaths and serious adverse events in those getting a placebo, the company said.”

“An FDA advisory panel is set to meet Tuesday to review data on Sutent and the Novartis drug. The FDA usually follows panel recommendations. Since the drugs already are on the market, doctors are free to prescribe them for pancreatic cancers. But the manufacturers need FDA approval to promote the medicines for that use,” Dey and Richwine report. “Pancreatic neuroendocrine tumors are rare and usually slower growing than other pancreatic cancers that kill within months after diagnosis. Both types have few treatment options.”

Read more in the full article here.

[Thanks to MacDailyNews Reader “Brawndo Drinker” for the heads up.]

23 Comments

  1. “Independent Committees” within the companies are committees within the companies. If they will disappoint Pfizer, other people will be in the committee other time, and no one wants this to happen.

    So, of course, they will recommend to end testing early.

    1. You really should not speak on subjects that you clearly don’t know anything about. Drug DMCs are indeed independent of the company. They are made up of clinicians and usually a statistician, and they monitor drug trials for both good and bad results. They will typically terminate a study due to one of 3 reasons: safety concerns, outstanding benefits, and futility.

      Neither Pfizer nor Novartis owns the DMC, and the DMC does not answer to them.

      1. Just look how many people from FDA worked for Pfizer and other related companies. Figure how much independent FDA can be in this situation.

        You really should not speak on subjects that you clearly don’t know anything about.

    2. The Drug Committees mentioned are actually paid for by the FDA. Each individual on the Committees are paid as independent contractors from the FDA budget. they don’t work for the drug companies, they work for YOU.

      I work for the FDA, and used to work in Contracting, where those purchase orders are processed. Each committee member is paid per meeting, no more than a couple hundred bucks, plus travel expenses, if I remember correctly.

  2. No! They are recommending ending the test because if they can cure the cancer they would go out of business. I think this happens alot in this industry!

    1. That’s an ignorant post. Let me tell you why:
      1. There is no one “cure for cancer” since there are a multitude of cancers, all different and with different causes. Cure this cancer and you have the possibility of using this cure to attack others, but you also make billions and get huge notoriety.

      2. Pfizer is not just in the cancer drug market. They are invested in a wide variety of medicines. By coming out with a cure to a type of cancer, they make billions and can fund all of their other work.

      3. If a research team were to find a cure for a type of cancer, and the company hid it because they would put themselves out of business, I guarantee you that the word would get out. Cancer researchers are not some millionaire club wanting to stay in business. They are hard working and believe in what they do. I know a lot of them, believe me.

      Everything in life is not some damned conspiracy. Some people are honestly working to make lives better.

      1. Researchers are paid well and if they are suckered into the process they will continue to be paid. If they make findings that do not fit with their employer ie Pfitzer etc they will be sacked. It was Pfitzer who killed nearly 60,000 people with Viox before the hopeless government said no more. IF anyone trusts Pfitzer after that genocide they need cold shower.

        1. You need to research basic facts before posting. Vioxx was manufactured by Merck, not Pfizer. But, Pfizer does continue to manufacture Celebrex and was also responsible, via acquisition, for the sales and promotion of Bextra which, like Vioxx, has been taken off the market.

          And “The Food and Drug Administration (FDA) estimates that Vioxx may have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003. The estimate is based on the number of prescriptions issued for Vioxx between 1999 and 2003.
          David Graham, the associate director for science in FDA’s office of drug safety, made the estimate based on 92.8 million U.S. prescriptions for Vioxx between 1999 and 2003. It’s part of a study Graham conducted in cooperation with Kaiser Permanente.”

          Finally, genocide is wrong word to use. Per Wiki, Genocide is the deliberate and systematic destruction, in whole or in part, of an ethnic, racial, religious, or national group.

          1. Well said. Thanks to you and a couple other posters here, there are some well-reasoned explanations and responses to some crackpot and paranoid theories. You gotta remember that a number of posters dump their crap here and then take their meds

  3. Drug trial may be ended for a variety of reasons such as the treatment has been shown to be effective vs control group earlier than anticipated in the study design ,or the treatment was associated with an increased risk of complications . An independent committee is independent and the FDA reviews the data to see if the marketing claims cans be supported .One suspects that this is good news WRT neurendocrine tumours

  4. If any company or individual, knowingly withheld information that would lead to the cure of cancer or any illness, for the financial benefit of the company, then the company should be destroyed and the leadership team tossed in jail for first degree murder of everyone who died because of that illness and reasonably could be cured, after such cure were discovered.

    No matter what religion or political party is involved. This type of thinking is not Capitalism it’s a crime, or it should be. Drug companies should be held to the Hippocratic oath, as do doctors. (I suppose that is not official anyways)

    Profits from keeping people sick is wrong. Reasonable profits from actual cures of the inflicted is right. We would never have Penicillin if the medical industry thought, “Oh, that would put me out of business.”

    1. The thing is about Steve Jobs health…

      In any case… I hope Steve Jobs somewhere watches the documentary, “Food Matters”

      The pharmaceutical companies provide incredible medicine in acute cases… But the doctors are forget other aspects of health.

      1. Been here for years, check the archives. The further the conversation drifts from topics specifically related to Apple, the greater the ignorance. Fortunately the readership here is so varied in background the ignorance is offset by some experts.

        BTW, my background is not medical regulation. But I know a little bit about it, so I can smell the BS when is being laid down.

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