Monday, April 7, 2014

So far good news but

Pfizer has developed a new drug called palbociclib (until it gets renamed by some team of marketing geniuses through some in depth market research and then gets a color, fancy packaging and more) that has provided some positive results in a small phase two clinical trial. I am not writing this  in terms of an overwhelmingly positive result because it isn't.

It is for one of the most common breast cancers - ER positive, Her2 negative - when they have become recurrent or metastatic. In some headlines the media has gotten hold of this and pumped up the results to be something else but we must remind ourselves of a couple of things before we run in circles thinking that it is that huge a game changer:
  • It was a clinical trial of 165 women.
  • Of those 165, many had their dose reduced because of side effects 13% dropped out of the study because of side effects.
  • But if you ask the doctor who ran the study, the drug was generally well tolerated.
A few more details. The drug delayed time before disease progression from 10.2 months to 20.2 months. Those who took the drug lived an average of 37.5 months compared to an average of 33.3 months in the control group - who received Femara (letrozole).

Breast cancer specialists who were not involved in the study are cautiously optimistic, as am I. It was not a blind study meaning that the doctors who ran it knew who received the new drug. And it was so small.

"A big question is whether Pfizer will be able to win approval of the drug based on this study. The Food and Drug Administration normally requires larger Phase 3 studies, but sometimes makes exceptions for drugs for cancers and other life-threatening illnesses.

If Pfizer can get early approval, the drug could probably reach the market next year. If the company must complete a Phase 3 study, which is already underway, approval might be delayed a couple of years, according to the ISI Group.

Garry Nicholson, president of Pfizer’s oncology division, told analysts on Sunday that the company “can envision the possibility” that the data from the Phase 2 trial would be sufficient for approval. He said the company had not gotten far enough in its discussions with the F.D.A. to be able to decide whether to seek approval now, however."

Pfizer wants the approval so they can start marketing it asap. And their investors aren't happy as it didn't live up to the initial expectations of  26.1 months vs. 7.5 months presented halfway through the trial. So now they have more pressure to get it on the market.

The FDA has previously given approval for drugs after Phase 2 trials but not always successfully? Avastin is a good example. It was approved for breast cancer after Phase 2 trials and then pulled from the market three years later, in 2011, because it showed it did not work after all. On the other hand, other companies have other breast cancer drugs in development.

So while I am happy to learn about this good news, I am hesitant because I firmly believe it needs more testing. This result is just too small to show us enough. Its not ready yet. We must have patience here.

1 comment:

Kathryn said...

I totally agree that it's not quite ready for prime time, but as someone with metistatic, ER+, Her2- breast cancer, I am glad there may be another option coming down the pike for when my current treatment fails. I just hope the phase III results do justify the current AACR conference hype!

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