I wanted to follow-up on yesterdays article, Ouch! Could There Be A Delay With Fast-Track, FDA Approval For New Anti-Myeloma Drug Carfilzomib?
Lori Murray, Director of Corporate Communications with Onyx, is quoted in the original Bloomberg article saying “Today’s news about trastuzumab-DM1 does not change our plans. We continue to believe there is a clear unmet medical need for patients with relapsed and refractory multiple myeloma.”
I ran my story with that quote, then immediately contacted Ms. Murray, seeking clarification. Her response:
“Onyx recognizes that pursuing an accelerated approval pathway has its risks, but, as I stated to the Bloomberg reporter, we do feel strongly that there remains a clear unmet medical need for patients with multiple myeloma who have exhausted all treatment options. In addition, the breast cancer treatment landscape is very different than myeloma with many more treatment options available to patients with breast cancer. We still plan to file a NDA by the end of the year for accelerated approval with the goal of bringing carfilzomib to patients as early as next year.”
She seemed unfazed and upbeat, pointing out differences between the large number of existing breast cancer therapies–which may have contributed to ImmunoGen Inc.’s failure to win an accelerated U.S. review–with the much smaller number of FDA approved multiple myeloma drugs.
So for now, I am remaining hopeful Onyx can deliver on their promise to get fast-track approval for carfilzomib sometime in 2011. If the company is unsuccessful, it certainly won’t be for lack of trying.
Feel good and keep smiling! Pat