The Puma Panel

I didn’t think neratinib was getting through. As much as I want more flexibility in prescribing and a more moderate drug approval pathway, why does it have to be neratinib?

Despite very modest clinical benefit, a lot of toxicity and a broad label, this morning’s FDA panel voted 12-4 in favor of more options for cancer patients. The panelists did seem to take patient selection seriously, though it’s unclear how that will pan out when Puma is loose in the market. What I’m curious about is whether patients will demand it, whether the patient representatives Puma paid to speak – the what-if-Mommy-dies, I-want-to-do-everything-to-fight-this types – are representative of the overall population.

Having never been without disease or off treatment, I’ve never entered this post-adjuvant watch-and-wait window. This is a rare and a very different clinical scenario than the early-stage patients who will complete treatment and never have another issue (that would be 92+% of patients), and it’s biased me toward rolling my eyes at the what-ifs. You’re fine. Go do something else. How does Puma find a healthy patient (to pay) to publicly agonize over not being accepted into ExteNET? How do you even make yourself available for this, and why?

It does catch me off guard to hear former patients getting emotional about their perceived risk of recurrence. And it’s a reminder that it’s entirely plausible that patients will wrap up Herceptin and decide that surgery, a taxane combined with an anthracycline or a platinum agent, radiation and all that Herceptin were all just barely holding Death at bay, and neratinib will take things over the edge. Which makes the timing of APHINITY so sweet, assuming the data is as good as we’re anticipating: you can have this extra protection from pertuzumab with minimal side effects. If it’s comfort you’re after, pertuzumab can provide it, emotionally, and, with regard to the AE profile, physically. We’re not going to get Herceptin/Perjeta and neratinib, right? This will not be a thing.

APHINITY aside, the other question is, of course, how complicit physicians will be in this nonsense. One physician speaking on behalf of Puma this morning used the “34% reduction in risk of recurrence” stat without noting that in actual cases, it represented about two people without recurrent disease at follow-up. Do you provide that context in the clinic? Do you counsel these patients on what the numbers mean? Do you care that their treatment decisions are emotionally driven? Even when the drug is so toxic? I thought toxicity was going to crush neratinib in the adjuvant setting, worse than the wonky study design stuff, and I predicted that doctors would be harder on QOL and toxicity than patients. (Patients could be willing to give the drug a try, knowing they could just quit.) But the panel seemed to go for how “tolerable” the drug could be with appropriate diarrhea prophylaxis. Is the attitude from both patients and physicians going to be, Well, why not? Is there a cost consideration here? These drugs alone cost thousands of dollars per month, not to mention the added clinical care from managing the side effects. Even sitting in an outpatient chair for fluid infusions is not cheap, and hospitalization is really not cheap.

Incidentally, the patient speakers at the panel on Puma’s invitation had no trouble at all with diarrhea. Like zero! Imagine that.

I stand by every horrible thing I’ve said about this drug – it’s poison and should not be routinely administered to healthy patients. I think APHINITY assures it won’t be. But, as this morning showed us, you never know.

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