I would like to take this opportunity to once again thank Dr. Eric Rubin, Vice President of Merck Oncology, for taking the time to update us on vorinostat’s projected timeline.
You may have noticed quite a bit of hedging and “drug company speak” toward the end of our interview. I want to point out that Dr. Rubin wasn’t intentionally being evasive. Well, actually he was! FDA rules are very strict about what anyone associated with drug companies can say about future projections involving any developmental drug. Additionally, drug company officials are never allowed to suggest alternated uses for a drug, other than those specifically approved by the FDA.
That said, I am under no such restrictions! Vorinostat is a histone deacetylase inhibitor, and some data suggest that bortezomib resistance may involve histone deacetylase activity. Therefore it was hypothesized that bortezomib in combination with vorinostat might show activity in patients with relapsed/refractory myeloma. As reported at the 2009 ASH meeting, bortezomib plus vorinostat yielded a 30% to 40% response rate. This included refractory patients and patients who were heavily pretreated with bortezomib.
Unlike a new, experimental drug like carfilzomib, vorinostat is already FDA approved for treatment of cutaneous T-cell lymphoma; therefore, oncologists are able to provide it to patients who did not respond to bortezomib as an “off label” prescription.
This is great news, since vorinostat seems to be an efficacious agent among patients developing a resistance to Velcade.
The bad news is some insurance carriers may not cover the cost, since vorinostat isn’t approved for use in multiple myeloma patients yet.
Good news, tempered by bad news–so what else is new?
All we can do is try and enjoy our Sunday! Feel good and keep smiling! Pat