By Saumya Joseph
(Reuters) – Bristol Myers Squibb Co said on Wednesday it planned to resubmit its application for an experimental multiple myeloma therapy by the end of July after the U.S. drug regulator declined to review the treatment as it sought more information.
The U.S. Food and Drug Administration asked for details on the manufacturing processes of the therapy, ide-cel, but did not request any clinical data in addition to what was provided in the original application in March, Bristol Myers and partner bluebird bio said.
Bristol Myers, which gained ide-cel through its $74 billion purchase of Celgene Corp, declined to give specific details on issues raised in the FDA’s “refusal to file” letter, saying it would look to expedite the agency’s decision by seeking a priority review label.
“Cell therapies are a bit more complicated and that is why there is a lot of questions and answers that we go back and forth with the health authorities,” Bristol Myers’ Chief Medical Officer Samit Hirawat said on a conference call.
“We are in a place where we do have the data, we will be able to compile it and provide it to the FDA,” he added.
Ide-cel belongs to a complex class of treatments named CAR-T therapy that involves taking immune cells from a patient, engineering them to attack tumor cells and infusing them back into the patient. If approved, it would be the first CAR-T therapy for multiple myeloma.
However, the regulatory decision is not likely to be viewed well by Celgene investors who stand to receive a contingent value right (CVR) payment of $9 a share if three treatments, including ide-cel, achieve timely approvals.
Ide-cel has an approval deadline of March 31, 2021, according to the terms of the CVR.
Last week, the review of liso-cel, another CAR-T treatment that is part of the CVR payout, with an approval deadline of Dec. 31, was extended by the FDA.
“The delays are disappointing, but they are delays that we feel do not impact the long-term potential of both of these therapies,” said Nadim Ahmed, president of hematology at Bristol Myers.
The value of the CVR
The company’s timeline would keep the CVR deadline intact, but raises questions as to whether it would be able to resolve the issues raised by the FDA in time for resubmitting the application by July, said Mizuho Securities analyst Salim Syed.
(Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Sriraj Kalluvila)
