Adam M. Brufsky, MD, PhD
As tomorrow’s Oncologic Drugs Advisory Committee (ODAC) hearing on neratinib approaches, the breast cancer community is waiting to see if the FDA panel will decide that the benefits of the agent outweigh the significant toxicity of diarrhea in patients with HER2-positive breast cancer.
, Brufsky, professor of Medicine, associate chief of Hematology/Oncology, co-director of the Comprehensive Breast Care Center, associate director of Clinical Investigation, University of Pittsburgh, discussed neratinib, overcoming resistance to HER2-targeted therapy, and the impact of newer agents in HER2-positive breast cancer.
What do you think of neratinib, given the impending ODAC meeting?
I think that Puma Pharmaceuticals has done everything that the FDA has asked. The drug met the endpoints. Clearly, there is a 2% to 3% improvement in progression-free survival at 2 years that actually widens at 3 years and even 5 years. What is interesting, is that the progression-free survival also appears to be highest in those with the highest initial risk. So, in other words, patients with larger tumors tended to have a better response.
The bottom line is that you never know what an ODAC panel is going to do, but on the other hand, I would be surprised if it didn’t get approved.
What has been the recent progress regarding resistance to HER2-targeted therapies?
Resistance to HER2-targeted therapies is an interesting question, because we are not sure if the resistance is truly to HER2, or it is to the underlying partner to the HER2 agent. There are strategies that people are employing—in other words, some people feel it may be a result of say, issues with receptor tyrosine kinase. Therefore, oral agents may work, such as lapatinib (Tykerb), neratinib, other drugs like poziotinib, tucatinib—these drugs may help.
... to read the full story